Calypte Only Company with Full Menu of Tests.

PRUUUUUSST !!!!  

ich verhalte mich nur dann wie ein weichei, wenn du mal wieder meinst, kritik zu widerlegen indem du beitragsmoderation der mods als hilfsmittel einsetzt.

über deine eben verfassten geistigen ergüsse stehe ich drüber....muhahahaha. es ist nicht mehr als das zickige gehabe eines kindes. mein kleiner sohn würde sich genauso verhalten.

nochmal für dich, mein früchtchen: die 0,20$ sind im juni gefallen, ob du dir das schönredest oder nicht...es hilft nichts. aber damit du dich als moralischer sieger fühlen kannst, gebe ich dir eine weitere chance indem ich sage:

noch im juni ein sk unter 0,20$. wenn die 0,20$ nachhaltig gebrochen sind, geht es bis auf 0,12$.

ob du dich jetzt wieder selbst belügt oder nicht... du wirst es spüren, mein süßer, gelle?

einen dicken schmatzer  

mich mit deiner gnadenlosen weitsicht, mr. 1-$-caly-to-the-sky-möchtegern-aktionär...

was machen die verkaufserlöse der rapidtests?

was machen die zulassungen?


kläre mich auf börsengott!

wann wird es sich im kurs wiederspiegeln? nächstes jahr, übernächstes jahr, über-übernächstes jahr? so wie du es vor 2 jahren auch schon gesagt hast. komm kerl, kläre mich auf und lasse deine göttliche aura auf mich überstrahlen...P  R  U  S  T!!!!!!!!


muahhahahaha  

U.S. FDA Approves New Anti-HIV Drug Aptivus(R) for Use in Combination Therapy
  Ridgefield, Connecticut (ots/PRNewswire) -
  - The Following Press Release Was Issued By Our U.S. Affiliate
Boehringer Ingelheim Pharmaceuticals, Inc. in The United States on
June 23, 2005
  Boehringer Ingelheim Pharmaceuticals, Inc. today announced that
the U.S. Food and Drug Administration (FDA) has granted accelerated
approval of Aptivus(R) (tipranavir) capsules. Accelerated approval is
a regulatory process that expedites the approval of therapies for
serious or life-threatening illnesses that provide meaningful benefit
to patients over existing treatments. This approval is based on
24-week data from ongoing studies. Longer term data will be needed
before FDA can consider traditional approval for APTIVUS. There are
no study results demonstrating the effect of APTIVUS on clinical
progression of HIV-1.
  The approved dose of APTIVUS is 500 mg taken with 200 mg of
ritonavir (APTIVUS/r), twice daily. APTIVUS must be co-administered
with ritonavir to boost the therapeutic levels of APTIVUS; otherwise,
levels of APTIVUS will be insufficient to inhibit HIV replication.
APTIVUS/r must be taken in combination with other anti-HIV
medications. APTIVUS 250 mg soft gel capsules will begin to be
available in pharmacies nationwide within two weeks of FDA approval.
  APTIVUS is a non-peptidic protease inhibitor that works by
inhibiting protease, an enzyme needed to complete the HIV replication
process. APTIVUS is able to enter infected immune cells and inhibit
HIV replication for many strains of HIV that are resistant to other
commercially available protease inhibitors (PI).
  Drug resistance is one of the major challenges that patients and
physicians face in the treatment of HIV. Resistance develops when the
virus mutates and is no longer suppressed by drugs that were once
effective.
  "The prevalence of drug resistant HIV underscores the need for new
treatments," said Dr. Daniel Kuritzkes, Associate Professor of
Medicine, Harvard Medical School, Director of AIDS Research, Brigham
and Women's Hospital. "APTIVUS offers an important new treatment
option to highly treatment-experienced patients or those with
multiple protease inhibitor resistant virus."
  APTIVUS (tipranavir), co-administered with 200 mg of ritonavir, is
indicated for combination antiretroviral treatment of HIV-1 infected
adult patients with evidence of viral replication, who are highly
treatment-experienced or have HIV-1 strains resistant to multiple
protease inhibitors. This indication is based on analyses of plasma
HIV-1 RNA levels in two controlled studies of APTIVUS of 24 weeks
duration. Both studies were conducted in clinically advanced, 3-class
antiretroviral treatment-experienced adults with evidence of HIV-1
replication despite ongoing antiretroviral therapy.
  The following points should be considered when initiating therapy
with APTIVUS/ritonavir:
   --  The use of other active agents with APTIVUS/ritonavir is associated
       with a greater likelihood of treatment response.
   --  Genotypic or phenotypic testing and/or treatment history should
       guide the use of APTIVUS/ritonavir.  The number of baseline primary
       protease inhibitor mutations affects the virologic response to
       APTIVUS/ritonavir.
   --  Liver function testing should be performed at initiation of therapy
       with APTIVUS/ritonavir and monitored frequently throughout the
       duration of treatment.
   --  Use caution when prescribing APTIVUS/ritonavir to patients with
       elevated transaminases, hepatitis B or C co-infection or other
       underlying hepatic impairment.
   --  The extensive drug-drug interaction potential of APTIVUS/ritonavir
       when co-administered with multiple classes of drugs must be
       considered prior to and during APTIVUS/ritonavir use.
   --  The risk-benefit of APTIVUS/ritonavir has not been established in
       treatment-naïve adult patients or pediatric patients.
  Pivotal Data
  Patients enrolled in the RESIST studies were failing their current
PI-based regimen, had received at least two previous PI-based
regimens, had received prior treatment from at least three classes of
antiretroviral agents and had documented PI resistance. These trials
examined the treatment response at 24 weeks of APTIVUS/r versus a
comparator group in which patients received one of several marketed
ritonavir-boosted PIs. Investigators selected a comparator PI that
offered patients the best opportunity for treatment response based on
resistance testing. The comparator PIs were lopinavir, indinavir,
saquinavir and amprenavir. In addition, patients in both arms
received an optimized background regimen of other antiretroviral
drugs. Patients in these trials were highly treatment-experienced and
the majority were at least possibly resistant to the comparator PI
chosen. The median baseline viral load and CD4+ count were 4.82 log10
copies/mL and 155 cells/mm3, respectively.
  The results of the RESIST studies showed that a statistically
significant greater percentage of HIV-positive patients taking
APTIVUS/r achieved a treatment response versus the comparator group
(40% vs. 18%). Treatment response was defined as a confirmed 1 log10
or greater decrease in viral load from baseline.
  In addition, a significantly greater proportion of patients
receiving regimens that contain boosted APTIVUS were able to reduce
the amount of HIV in their blood to undetectable levels than in the
boosted comparator group. At 24 weeks, 34% of patients in the
APTIVUS/r group and 16% of patients in the boosted comparator group
achieved a viral load of less than 400 copies/mL, and 23% vs. 9%
achieved less than 50 copies/mL.
  Patients treated with APTIVUS/r also experienced greater increases
in their immune cells than those treated with a ritonavir-boosted
comparator PI. The median change from baseline in CD4+ cell count at
week 24 was +34 cells/mm3 in patients receiving APTIVUS/r (n=582)
versus +4 cells/mm3 in the comparator group of ritonavir-boosted PIs
(n=577).
  "The approval of APTIVUS marks an important milestone in
Boehringer Ingelheim's long-standing commitment to the HIV
community," said Burkhard Blank, M.D., Senior Vice President, Medical
and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals,
Inc. "Our HIV research and development program is dedicated to
bringing innovative HIV therapies to patients and their healthcare
providers."
  Safety Information
  APTIVUS co-administered with 200 mg ritonavir has been associated
with reports of clinical hepatitis and hepatic decompensation
including some fatalities. Extra vigilance is warranted in patients
with chronic hepatitis B or hepatitis C co-infection, as these
patients have an increased risk of hepatotoxicity. All patients
should be followed closely with clinical and laboratory monitoring.
Liver function tests should be performed prior to initiating therapy
with APTIVUS/r and frequently throughout the duration of treatment.
Patients who develop symptoms of liver problems, such as fatigue,
loss of appetite, yellowing of the eyes or skin, or liver tenderness,
should stop taking APTIVUS/r treatment. Patients with moderate to
severe hepatic insufficiency should not take APTIVUS/r.
  APTIVUS/r has an effect on the way some medications are eliminated
by the body, and if these medications are combined with APTIVUS/r, an
elevation of their level may occur, which can lead to serious and/or
life-threatening side effects. This concern is due to the extensive
drug-drug interaction potential of APTIVUS/r. Some medications from
the following drug classes must not be taken with APTIVUS/r:
antiarrhythmics, antihistamines, ergot derivatives, GI motility
agents, neuroleptics and sedatives/hypnotics.
  Other medications taken with APTIVUS/r may require a dose
adjustment or additional monitoring, including those in the following
classes: reverse transcriptase inhibitors, protease inhibitors,
antifungals, antimycobacterials, calcium channel blockers,
antidepressants, HMG-CoA reductase inhibitors, hypoglycemics,
immunosuppressants, narcotic analgesics, estrogens, PDE5 inhibitors,
anticoagulants, antibiotics, and drugs to treat alcohol dependence.
Patients should discuss the potential for drug interactions with
their healthcare provider.
  APTIVUS, a sulfa-containing drug, should be used with caution in
patients with a known sulfa allergy. Mild to moderate rashes
including urticarial rash, maculopapular rash, and possible
photosensitivity have been reported in subjects receiving APTIVUS/r.
In Phase 2 and 3 trials rash was observed in 14% of females and in
8-10% of males receiving APTIVUS/r. Additionally, in one drug
interaction trial in healthy female volunteers who were administered
a single dose of ethinyl estradiol followed by APTIVUS/r, 33% of
subjects developed a rash. Rash accompanied by joint pain or
stiffness, throat tightness, or generalized itching has been reported
in both men and women receiving APTIVUS/r. Women taking
estrogen-containing medications with APTIVUS/r have an increased risk
of developing a rash.
  Like other protease inhibitors, APTIVUS/r may be associated with
the development or worsening of diabetes, elevations in cholesterol
and triglycerides, abnormal distribution of body fat, immune-related
inflammatory response to infections and increased bleeding in
hemophiliacs.
  APTIVUS does not cure HIV infection/AIDS or prevent the
transmission of HIV to others. Patients may continue to develop
opportunistic infections and other complications associated with HIV
disease. There are no adequate and well-controlled studies in
pregnant women for the treatment of HIV-1 infection. APTIVUS should
be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. The long-term effects of APTIVUS are
unknown at this time.
  The most commonly (greater than or equal to 2%) reported side
effects of at least moderate intensity in patients enrolled in the
RESIST studies taking APTIVUS/r are gastrointestinal, including
diarrhea (10.9%), nausea (6.7%), vomiting (3.4%), and abdominal pain
(2.8%). Fever (4.6%), fatigue (4%), headache (3.1%), bronchitis
(2.9%), depression (2%), and rash (2%) also occurred. The most common
(greater than or equal to 2%) moderate to severe laboratory
abnormalities in patients enrolled in the RESIST studies taking
APTIVUS/r are elevated triglycerides (45.1%), elevated liver enzymes
(17.5%), elevated cholesterol (14.6%), decreased white blood cell
count (3.6%), and elevated amylase (2.9%).
  Ongoing Clinical Trials
  Boehringer Ingelheim is committed to further understanding the
clinical utility of APTIVUS for the treatment of HIV. Ongoing studies
will continue to evaluate the safety and efficacy of APTIVUS. The
safety and efficacy of APTIVUS in pediatric patients or in
treatment-naïve adults have not been established. Phase 2 and 3
studies in these populations are fully enrolled and ongoing. In
addition, Boehringer Ingelheim will continue to study APTIVUS in
women and hepatitis co-infected patients, and conduct further
pharmacokinetic interaction studies of the drug.
  Boehringer Ingelheim
  Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. VIRAMUNE(R) (nevirapine), a product
of original research done at Boehringer Ingelheim, was the first
member of the non-nucleoside reverse transcriptase inhibitor (NNRTI)
class of anti-HIV drugs. Boehringer Ingelheim is involved in basic
research and is committed to the development of tipranavir and
improving HIV therapy by providing physicians and patients with
innovative antiretrovirals.
  For more information on Boehringer Ingelheim, please visit
http://www.boehringer-ingelheim.com .
  Web Site: http://www.boehringer-ingelheim.com
ots Originaltext: Boehringer Ingelheim GmgH
Im Internet recherchierbar: http://www.presseportal.de
Contact:
Outside the U.S.: Judith von Gordon of Boehringer Ingelheim GmbH,
External Communications, +49-61-32-77-3582, +49-61-32-77-6601 (Fax),
press@boehringer-ingelheim.com, Within the U.S.: Ann Davin of
Boehringer Ingelheim Pharmaceuticals, Inc., Public Relations Manager,
+1-203-791-6318, +1-203-791-6442 (Fax),
adavin@rdg.boehringer-ingelheim.com
 

Time & Sales most recent  next page
Rec. Time Action Price Volume
9:38:18 AM Trade 0.19  10000  
9:38:18 AM Bid 0.19  73000  
9:38:08 AM Ask 0.2  15000  
9:35:20 AM Ask 0.2  25000  
9:35:12 AM Ask 0.2  15000  
9:35:12 AM Ask 0.2  25000  
9:35:12 AM Bid 0.19  83000  
9:35:10 AM Trade 0.2  10000  
9:33:56 AM Trade 0.2  4000  
9:33:36 AM Trade 0.2  2000  
9:33:36 AM Ask 0.21  230500  
9:33:36 AM Ask 0.21  5000  
9:33:36 AM Trade 0.2  1000  
9:33:32 AM Trade 0.2  500  
9:33:28 AM Trade 0.2  19000  
9:30:04 AM Ask 0.36  3000  

 

gemeint... Is klar.

Wann kommen deine vorhergesagten 0,12 ? Sags uns bitte !  

 

als sk nicht unbedingt...aber als neues ATL bestimmt. sollte es dann soweit sein und ich bekomme es rechtzeitig mit, werde ich wohl auch einen kleinen zock auf 20 -30% mitmachen...

an der 0,12$ sollte sie dann ersteinmal wieder nach oben abprallen. man könnte hier dann ev. auch auf 80% gehen, das halte ich aber für zu gewagt...  

es nach der offenbarung deines charakters über monate hinweg auch nicht mehr unbedingt anstreben. du lernst es nur, wenn du es ganz heftig spürst...  

Närnbäch beim Spiel ? Dann könntest Du mir noch mehr deiner Infos geben !?  

unterwegs...  

würde mich dann umgehend mit dir dort in der nordkurve treffen. du würdest mich dadurch erkennen, dass ich meine 1,95 in eine totenkopffahne eingehüllt habe...  

 

 

ernst gemeint wäre....aber zur klarstellung: nicht der beste aber der realistischste hier...


hast du sonst noch was zu entgegnen, um mir und allen klarzumachen, dass ich immer die unwahrheit erzähle?

der widerstand bei 0,20$ wird immer brutaler:

Support/Resistance
Type Value Conf.
resist. 0.40 4
resist. 0.33 12
resist. 0.30 7
resist. 0.28 3
resist. 0.27 10
resist. 0.25 3
resist. 0.24 3
resist. 0.23 17
resist. 0.22 8
resist. 0.21 4
resist. 0.20 30
 

Time & Sales  
Price Size Time
0.19 1000 15:59:28
0.19 1000 15:59:28
0.19 1000 15:52:24
0.19 1000 15:52:24
0.19 1000 15:51:03
0.19 1000 15:51:03
0.19 1000 15:50:41
0.19 1000 15:50:41
0.19 12700 15:50:26
0.19 4300 15:50:26
0.19 12700 15:50:26
0.19 4300 15:50:26
0.19 29700 15:44:03
0.19 700 15:43:57
0.19 2500 15:43:57
0.19 1800 15:43:57
0.19 5000 15:43:57
0.19 300 15:43:31
0.19 3500 15:43:23
0.19 96500 15:43:04
0.19 10000 15:39:19
0.20 10000 15:37:51
0.20 10500 15:29:17
0.20 2000 15:24:05
0.20 5000 15:07:34
0.20 1500 14:59:05
0.19 10000 14:58:02
0.19 10000 14:39:16
0.20 1000 14:37:37
0.19 10000 14:36:40


womögliche kommen die 0,12 sogar noch im juni...dann würden hier einigen ganz schön die kinnlade runterfallen und selbst ich müsste dann sogar einsteigen bei caly....muhahhahahahahahaa....prust.....aber ich würde zu 0,17 das s(t)inkende schiff wieder verlassen...


wie kade immer sagt: S T R O N G!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!


volles rohr aufrecht in den untergang...  

bemerkenswertes aus dem Teil Frage & Antwort bezugl. China Geschäft

CC May 17, 2005

Dr. George CEO
Thank you for joining us on today’s call. The past quarter was one of accomplishments and change for Calypte. We continue to move our products through the regulatory processes and closer to launch. Yesterday we announced the approval of our Rapid HIV Test in Uganda and this morning we announced the completion of our trials and preliminary results out of China. We also initiated a major restructuring plan to discontinue older product lines and minimize expenses with the intent of maximizing cash resources and enhancing profitability upon launch of our Rapid HIV Testing Platform. A few weeks ago we announced the signing of a letter of intent with Maxim Biotech to explore the sale of our Legacy Products; our Urine EIA and our two Western Blots. Maxim and Calypte have since signed a manufacturing service agreement and are moving forward to complete the sale of our Legacy line of products. If and when the definitive agreement is fully executed Maxim would also assume the Rockville Manufacturing Facility lease and associated Intellectual Property and equipment lease obligations. Rick Brounstien will provide you a more detailed status report on this transaction as part of his review of the quarterly results then I will come back and take you through a review of operations. Rick…

Rick Brounstien CFO
Thanks Richard, and welcome to the Calypte update for the quarter ended March 31st 2005. Revenues for the first quarter of 2005 decreased 32% or $306,000 to $665,000 compared with $971,000 for the first quarter of 2004. While the differences have a lot to do with the consolidation of manufacturing from Alameda into Rockville, going forward we anticipate Rockville to operate at a zero dollar burn rate to Calypte. Of our current and ongoing products the HIV 1 BED Incidence Test is on the market and our HIV Rapid Products are close to generating revenue as the launch into Africa and China draws near. Effective May 1st the three other products which we referred to our Legacy Products; the Urine EIA, the Urine Western Blot Supplemental Test and the Blood Western Blot Supplemental Test will be manufactured by Maxim Biomedical. Initially Maxim will produce product for Calypte on a contract manufacturing basis when we expect to complete the necessary approvals and ultimately transfer the business to them subject to a definitive agreement. While there is interests by both parties in Maxim acquiring the business, today what we have is an outsourced manufacturing agreement and a letter of interest from Maxim to complete an acquisition. Affectively the current Legacy sales will continue for Calypte’s account at least into June of this year. And I would expect the second quarter run rate to be similar to Q1 of 05. All of the insurance labs purchased at least once during the first quarter and this business appears to be returning to historical levels. We’ve completed the technology transfer of the Urine EIA Test to Rockville and filed our submission with the FDA. Maxim is continuing with our plan and is preparing to build the Urine EIA inventory at Rockville to maintain the products availability as the transition from Alameda to Rockville completes as planed. We expect the momentum for the BED Incidence Test during 2005 and beyond to grow stronger as the CDC continues to conduct its workshops to train the trainers on the application and use of the test. While still modest sales increased 26% from last year quarter Q4 of 04 to $39,000 in Q1, of 05 and we expect this trend to accelerate. While the product is available for sale it would not be reasonable to consider the Incidence Test fully launched until all the workshops are complete. We are currently at a run rate of less than 100,000 tests per year. However, the ongoing expectation from the CDC is that demand will grow to 2 to 5 million tests annually over the next couple years. We see this expanding interest resulting from the CDC’s endorsement of this product as the key surveillance tool in the fight against AIDS. Cost of Goods Sold was $1,500,000 in the first quarter of 2005, a decrease of 23% or $460,000 from almost $2,000,000 in the first quarter of 2004. In many ways the numbers are just not comparable, only about $50,000 is related to lower or variable costs on lower sales. Otherwise, in 2004 we were running Alameda, California in preparation to consolidate the Urine EIA product in Rockville, which has now been completed. Elimination of Alameda rents overheads and personnel saved the Company over $250,000 between quarters. However, our plan to build Urine EIA in Rockville was in transition in Q1, 05 and we are not yet absorbing the overhead with Urine EIA manufacturing in Rockville. Also, as a result of the manufacturing relocation almost half of the cost of goods in Q1, 05 is inventory adjustments as we finalize the transition. As we implement the restructuring we have cut Rockville manufacturing head count by over 50% reducing the facility to approximately a break-even at today’s revenue levels. As a result of the manufacturing services agreement with Maxim, they have an arrangement that locks in a zero dollar burn rate on our Legacy Products, with the potential for upside, assuming they complete the acquisition. The Company will incur one time costs related to the restructuring in Q2, 05 as we transfer our inventory to Maxim to facilitate production and sales under the manufacturing services agreement. Thereafter, we expect to be fully outsourced and if so our second half revenues result immediately in positive growth margins. R&D expense increased 41% or $221,000 to $762,000 in Q1, 05 from $541,000 in Q1, 04 the primary drivers of the increased R&D are - First, increased clinical testing – Second, higher travel costs to support the launch of the Rapid Platform Technology in Thailand and China and – Third, increase technical consulting time to support the Ani Technology Platform. SG&A costs decreased by $782,000 or 36% to $1,414,000 in the first quarter of 2005 compared to SG&A costs of $2,196,000 in the first quarter of 2004. There are a couple of large components that netted this decrease; most of the decrease is in salary expense. Last year we transitioned CEO’s to Richard and did not re-hire his VP of Government Affairs position, we also eliminated the role of Executive Chairman. Legal and auditing came down by approximately $100,000 as we completed a change of auditors a year ago. We have now re-qualified to use short form SEC filings such as a registration statement using SEC Form S3. The loss from operations dropped by over $700,000 and this is reflected in a reduced burn-rate which was about $800,000 a month in this first quarter of 2005 versus a steady $1,100,000 a month last year in 2004.
And with the restructuring expected to be completed largely during this second quarter of 2005 we expect to realize additional significant reductions in second half of 2005. As I noted above we’ve already cut manufacturing payroll by over 50% as of the end of April. Net interest and other expense are primarily non-cash. The first quarter 2005 cost of $260,000 approximated Q1 of 04 was a primary component being approximately a $200,000 Mark-to-Market charge valuing the change in the counting value in the Anti-Dilution provision of the stock issued in the May and July 2004 PIPE transactions based on a Binomial Valuation model following the guidelines for FAS 150 and the related EITF issues. This is part of a $1,800,000 anti-dilution obligation which has been classified as a current liability on the balance sheet. If we issue the shares to fulfill the anti-dilution provision based on an affirmative vote by our stockholders at the scheduled June 30th annual meeting we would re-classify the $1,800,000 to equity. Cash at March 31st in the Balance Sheet does not reflect the closing of this early April 2005 financing. We exited April with approximately $4,500,000 in cash. The 2005 Credit Facility also provides us, subject to certain requirements, with a $5,500,000 borrowing capacity. Following the restructuring we have an operating burn rate that together with our financial resources expect it to allow us to achieve our milestones effectively through the end of the year. Id like to now turn the call back over to Richard.

Review of Operations
Thank you Rick, now I’d like to review operations. At long last we were especially pleased to announce this morning that the clinical trial in the Peoples Republic of China has been successfully completed. A preliminary report for the Oral Fluid and Urine HIV 1 – 2 assays has been completed by the Chinese Centers for Disease Control and Prevention. The trials conducted by the Chinese CDC involved approximately 1500 subjects composed of HIV positive, HIV negative and subjects with other viral diseases. The results were truly outstanding and the consistent performance by our Rapid Tests remains encouraging. The accuracy of the Urine and Oral Fluid HIV 1-2 Rapid Test was established by comparison to results from Enzyme Immunoassays of Western Blot Assays already approved already approved by the Chinese SFDA. In this study concordance of the EIA Testing to the Oral Fluid HIV 1-2 Rapid Test was 99.9% and over 99.5% for the Urine HIV 1-2 Rapid Test. The very strong performance of our assays in this study conducted by this prestigious Chinese public health institution provides additional strong validation of our technology. The Calypte HIV 1-2 Blood Rapid Test and our Urine and Blood HIV 1 Western Blot assays were also evaluated as part of this trial but the reports on their performance were not available in time for this Conference Call. We will provide this information as it becomes available over the coming weeks. We will immediately prepare our application for review by the Chinese State Food and Drug Administration. We expect to submit that application to the SFDA in the current quarter and remain confident that that application will receive the prompt attention of the Chinese SFDA. Approval is expected to come in late summer or early fall of 2005. While we’re waiting for the SFDA approval we will be completing manufacturing provisions in China. To that end we are actively recruiting personnel in the areas of quality assurance, quality control, regulatory and manufacturing. We have been notified by Ani Biotech that our automated equipment is ready for shipment to China. A team from Calypte is going to Ani’s facility in Finland for training on the use of this equipment in June and our plans call for the equipment to be installed in our plant in China and for that plant to be ready to service the Chinese market as soon as the SFDA approvals are received.

Progress around the World
While we are very excited about progress in China great strides are being taken in other parts of the world. Yesterday we announced the completion of the regulatory process in Uganda and the first approval of our Rapid Test Products. In addition we have started studies in South Africa. Testing of the Blood Rapid Test has been completed and the testing of the Oral Fluid and Urine is scheduled to begin in late June or early July. Testing in Kenya is set to begin in June. Testing in Cameroon and Botswana is ready to go in late summer. Clinical studies have already begun in Vietnam. In addition to China, Vietnam and Africa we are set to begin the regulatory process in India. As we speak Dick Van Maanen our Vice President for Operations is in India working with our distributor to begin those studies. India has the second largest number of cases of HIV infection and the second largest population of any country in the world. We are very confident that our Rapid assays as well as our Incidence products will play a significant role in India’s effort to curb the spread of HIV among its population.

BED Incidence Test
I would like to discuss the progress of the BED Incidence Test. This assay was rapidly put into production at the end of last year and our first shipments occurred in October of 2004. Sales of this product currently are modest, the sales are growing and the train the trainers workshops continue and we expect this ramping up to continue through 2005 and 2006 until they reach levels of approximately 5,000,000 tests per year in 2007. This assay was originally projected to be a surveillance tool and not used for clinical purposes. Now there are increasing amounts of data suggesting that there is in fact significant clinical benefit in identifying those infections that were recently acquired. Individuals with acute infections have high viremia and are in high risk for transmitting the disease. When these patients are put on early therapy, the viremia is reduced and the course of disease in these people is usually much milder than when treatment is instituted later in the course of the disease. Calypte has been advised by both the CDC and the FDA that an IDE application for use of this test for clinical purposes would be welcomed. Our first meeting with the FDA in pursuit of this claim takes place in July. We believe that the expansion of the use of the BED Incidence Test and innovative new products, such as the Rapid Diagnostic Incidence Test being developed in cooperation with the CDC will be an important product line for Calypte.

Progress Summary
I am very excited the progress we have made since my last report to you. It is difficult to always be absolutely accurate when predicting the time in which these complicated tasks will be completed. But we continue to execute our plan to develop these innovative new products and get them to the market place as quickly as possible. That plan validates our technology, the plan that obtains regulatory approval, a plan that establishes manufacturing and a plan that later this year begins sales of our Rapid Tests. Since I became President, CEO in January of 2004 I have been diligently rebuilding the Company and trying to focus our attention and resources on the least resistant path to revenue and profitability through our current product line. In evaluating this path it became clear that each product line the Company possesses had its own set of challenges. In January of 2004 the Rapid Test had great promise but very little clinical data. No large scale or repetitive scientific validation, incomplete and restrictive IP issues and no regulatory strategy. Since then we have firmly and diligently addressed these critical elements by validating the technology in three independent clinical trials involving almost 3,000 subjects. Acquiring all the necessary IP licenses and firmly entering the regulatory process in China and in Africa. On the other end of our line of the Legacy Line of products were FDA approved and established in the market place. Our EIA and Western Blot Product lines are strong diagnostic tools with reliable customers that focus on a distinct opportunity in the HIV market. However, going forward we see considerable near term international growth opportunities in the Rapid HIV and BED Incidence Testing markets. Our decision to restructure is in keeping with our objective to distribute our resources toward our future - the Rapid HIV Testing Platform and the BED Incidence Test. As a Company that is spending heavily on Intellectual Property, on regulatory pursuits, manufacturing facilities and product launches I need to focus our resources on what we believe to be the greatest opportunity – our Rapid Test. To this end we have entered into a contract manufacturing agreement with Maxim Biomedical and we currently are expected to conclude a definitive agreement to complete the sale of our Legacy business. In addition to the Rockville restructuring later this summer we also plan to close the administrative offices located in Pleasanton, California and re-locate those activities to Lake Oswego, Oregon. Lake Oswego is a suburb of Portland. This location was selected to consolidate all of our US activities into one location. Our main R&D location was already in this area. When I came to Calypte we operating manufacturing facilities in California and Maryland; R&D was located in Maryland and Vancouver Washington. It was extremely expensive and very difficult to efficiently oversee these scattered operations. Whilst the restructuring is completed our US operation will be reduced to approximately 15 to 20 people located in the same city. And our burn rate will be reduced from $1,100,000 per month level of 2004 to approximately $500,000 per month. I anticipate staffing the US to remain at this level for the foreseeable future and anticipate near term personnel and expenditure growth to come out our Beijing, China site. This restructuring will clear the decks to permit the Company to focus its attention and resources on what we believe to be the future of the Company. Sixteen months after my appointment as CEO Calypte is a much different Company. We have completed the development of three important new Rapid HIV 1-2 assays. One for use with urine samples, one for use with oral fluid samples and one for use with blood samples; these assays have been fully validated. We have acquired all the licenses required to sell these products world wide. We have established manufacturing in Thailand. For the past six months Calypte has been conducting clinical studies in several countries in pursuit of regulatory clearances. We are also please to announce the receipt of the first letter from Uganda clearing the way for sales of Aware® HIV 1-2 Rapid Test for use with blood, oral fluid and urine. Our progress this reporting period has been remarkable. We are a very different Company from what we were in January of 2004. We have streamlined our operations, dramatically cut our costs and we are focused on those activities that will create revenue and move the Company forward. All of us here at Calypte look forward to the rest of 2005. Now I’d like to open this up for questions so operator, please go ahead.

Q&A
Moderator: Our first question comes from the line of Tom DeHooty of Innovative Asset Management, please proceed.

Q. When do get to volume shipments on the HIV tests?
A. Ya, I wish I could answer that precisely but I can’t. We are currently involved in bidding on several national tenders in different countries. And as you know most of the large volume sales for HIV tests are to governments through the tender process. The first of those tenders should start to be awarded sometime next month and we have absolutely no way of knowing at this point whether we will be successful or unsuccessful with those. I think most certainly if things continue to go well in China, as I’m confident it will go well, I think there’s a very good opportunity to make some significant sales in China the second half of 2005. As of right now we do not have any large orders for our rapid tests, but we are very actively marketing as I said earlier, Dick Van Maanen is right now in Asia trying to get some of these sales going. So, that’s about the best answer I can give at the moment Tom.
Q. Who are you competing with in these government tender offers and what other competitive products out there are there?
A. You know most of the big tenders right now are for blood tests and as I’ve said many times on these calls, really there are a lot of other people who are selling blood tests. Unfortunately a lot of the people selling those blood tests are infringing on Intellectual Property and paying no royalty’s and it makes it difficult to compete with them in that market. When we get sales wrapped up for oral fluid and urine, it’ll be a different story. For oral fluid we really have only one legitimate competitor and for urine I’m not aware of any other competitors. The trick is to get through these regulatory processes that we are going through right now; this opens the door and I think we’re making great progress there.
Q. Just one follow-up on this. So the bids that you have in are they for urine tests? Or are they for blood?
A. The one’s that we currently are bidding on, these are for blood.
Q. And at what point can you start bidding the urine product?
A. Well, in some countries it’s a question of; if we are talking about national tenders, there are country’s now where we are eligible to bid but we have to wait until those tenders come about. In other words those are only open at specific times. In South Africa, we will be able to bid on tenders there after we complete the second phase of the evaluation there. The blood test has already been evaluated and late June early July we will begin the evaluation of the oral fluid and urine. In China we will be able to bid on contracts in China following SFDA approval and as I said in my presentation that should occur in the last half of 2005. I’m hopeful the end of the third quarter; beginning of the fourth quarter 2005.

Moderator: Your next question comes from the line of a private investor.
Q. My question is about the Ani equipment; it’s being shipped to China?
A. Yes, it is.
Q. The way I understood it the current format is the dip-stick, is that correct?
A. Well, just to clear up any possible misconception about the Ani equipment and what it can be used for; the Ani equipment is not specific for the Ani format at least not (noise over line) the equipment to make the goal pads to stripe the nitro cellulose is universal for any lateral flow assay. There are only certain parts of the Ani equipment that are specific for the Ani format versus the dip stick format. So, really the simple answer is you can use the Ani equipment to make either the Ani format or the dip stick format.
Q. Now, as far as the United States then, is there going to be a manufacturing plant in the Portland area?
A. You know we are certainly not abandoning the US market. I want to make that absolutely clear. We are diligently working on the Incident Blood Rapid Test; the Rapid version of the BED assay with the CDC. And that research is going extremely well. The first version of that assay we intend to have for a blood application. Shortly after that we will start working on the oral fluid application for that assay. As I’ve said many times I sincerely believe that when that test is available that it will obsolete other blood tests. So we definitely intend to go for the US market for that particular product. We also plan to go for the US market with the BED ELISA test and that’s the purpose of the FDA meeting. At the moment for the BED Incidence Test we are going to use a contract manufacturer here in the United States. Once we get a little bit (this is the one we’re currently selling) once we get closer to time when we want to start doing clinical trials for the BED Rapid Incidence Test we will be looking to set up a manufacturing site here in the United States for that purpose. So, right now we do not currently operate a manufacturing facility, but the good thing about manufacturing rapid tests is it’s fairly easy to set up such a manufacturing facility and we probably later plan to come back to that.
Q. And you’ll have to have FDA approval on that plant, before you can sell product?
A. Well, you would have to have FDA approval no matter where you manufactured it. Even if we still had the facility in Rockville, if we started making rapid tests the fact that it’s an approved facility certainly has advantages but it would still have to be approved to manufacture that specific product.
Q. And have you had any kind of feedback at all from the FDA, regarding the over the counter product?
A. We have not even had a conversation with the FDA about an over the counter product. Although we are pursuing opportunities in other countries right now for over the counter products, those negotiations are at sort of a critical point and I’m not going to name country’s right now where those negotiations are occurring but we actually do have products in the regulatory pathway.
Q. And in terms of the United States an over the counter product you mentioned before about a pre-counseling and a post-counseling aspects, but there’s also another factor that is a little more difficult, and that is that, in the post when someone already knows or can determine their results it eliminates their need for a post counselor. Can you address that issue?
A. I don’t think I understood what you said, could you repeat it.
Q. Ya, when someone has the results of their test, and the requirement is that there be a post counseling session, when they already have the results determined there’s no incentive for the person to complete that post counseling session.
A. Well, I disagree with you, because right now I don’t think it’s possible to have an over the counter product that can deliver a definitive result to a customer with just one test. FDA has steadfastly required that there be a screening test followed be a confirmatory test. I think that unless some technology appears that currently I’m not aware of the way that over the counter testing will have to be done in the United States is that there will be a screening test, you get a result and based upon that result you determine whether or not you need to have the confirmatory testing performed. And so, I think there will still need to be a post test counseling available to those individuals to explain the results of that confirmatory testing. The over the counter testing situation has always been a little complicated and I think it’s going to continue to be complicated but we really do believe that it’s quite manageable if one acts responsibly.

Moderator: Your next question comes from the line of Peter Delgrasso of UBS Financial Services please proceed.

Q. Dr. George reducing the head count to 15 to 20 people is not going to leave a lot of room for marketing and what not, is there any consideration a cooperative plan any of a better-healed company come and help with the marketing and distribution?
A. We continue to have conversations with various companies about that type of an arrangement but as of right now we don’t have anything in place. Now as far as internationally is concerned we do sell through distributors in the international arena. And you’re right we don’t have a lot of people on our payroll out there selling product but we do have a lot of feet on the street from the various distributors. The two people we do have currently employed; Dick Van Maanen and Wido Lipoly and myself, our job is to assist our distributors in getting out there and selling the product. Right now you have to remember we really are focused on the international market, we’re not really trying to sell into Europe we’re not trying to sell into Japan or New Zealand, Australia, we’re really focused on those countries where HIV is the biggest problem. And I think we have some distributors in these countries. We’re going to have some additional word about adding new distributors very soon.
Q. And as you’re going forward into these countries are your relationships basically with the governments and health organizations that you’re marketing to specifically?
A. Yes, I would say that without a doubt that probably is the biggest market. But we’re also looking to sell to those buying agencies who, the donor agencies, people who are buying in larger volumes and donating to those countries either directly or indirectly. And those agencies are USAID, WHO, CDC and others. You know we’re trying to cover the spectrum here. There is of course some non-governmental markets that are available in Africa and most of those are available to us now since they, in many countries you only need the regulatory approvals to sell to the government. So, we’re going for both of them but there’s no question the larger numbers is with the government sales.

Moderator: Your next question comes from the line of Robert Pedrasa of Tiger Trading, please proceed.

Q. Could you pleas comment on what you see as the potential in terms of units for sale? And I ask that question because, clearly you’re already developing manufacturing facilities and you don’t do that unless your really anticipating approval and obviously sales. So what are you projecting in terms of units and in the different products as well as what would be the pricing of these products into the Chinese market?
A. Well, China is sort of the focus of our activities right now and we’re very fortunate to what I think is an excellent partner in China and that is the Marr Group. As you know we formed a joint venture with the Marr Group for the China activity. And that joint venture right now is focused on selling into the Chinese market. Marr has been active in China in different areas for about 15 years and they know a lot about the China market, and they know a lot about how to sell into the China market. When I start throwing numbers around concerning the China market it makes me uneasy to even talk about these numbers but..
Q. I can handle the numbers.
A. Some examples that I frequently give is one particular market that we’ve been trying to cultivate contacts for is for the sex workers in China. There is a program going on right now to monitor the commercial sex workers to subject them to HIV testing three or four times a year. Currently there are 30,000,000 sex workers in China. So, just doing some simple math if we had no other segment of the China market besides the commercial sex workers that could be as many as 120,000,000 per year. But as I often say there really are no small markets in China. Border control is another big area where a lot of HIV testing is being done, literally millions of tests per year. In 2004 the Chinese government came out and said in a press release that they planed to offer testing to every citizen of China. One of those big segments of the Chinese population is farmers. There are 600,000,000 farmers in China. The thing that really excites me in China; I don’t really get that excited about the blood test in China just to be honest with you, there are a lot of other blood testing on the market in China; although we think ours is probably as good or better than any of them in terms of quality and we actually can compete with them fairly successfully price wise. I believe that the real market in China is going to be oral fluid and urine; for the simple reason that; if you’re going to start testing 600,000,000 farmers, the only way you’re going to do that is to take your product and put it in a van and go out and find those farmers where they are currently living. Those farmers aren’t going to come into the city to get tested. With oral fluid and urine you can take testing to them anywhere, especially the oral fluid. I just reported to you the clinical trial that we just did in China with our oral fluid test. Our comparability to the ELISA test, which is the gold standard, was 99.9% that was the accuracy that we saw. We did not have a single false positive result in our clinical trial, which I think is pretty remarkable. And we will be, unless I am very wrong, when we get approval we will be the only approved oral fluid test on the China market. And we will be the only approved urine test on the China market. So, I think this is a great opportunity and my biggest concern going in is being able to manufacture enough tests to meet demand.
Q. The cost per unit could you shed any light there?
A. I really don’t want to put that out on a; this is information that I really don’t want to give to my competitors at the moment.
Q. I understand, thank you for your time.

Moderator: You have further questions at this time.

Dr. George
Well, thank you ladies and gentlemen and thank you for the really excellent questions. This has been in my estimation one of the most significant reports that I’ve been able to give to you. So, I’ll turn this back over to the operator.

End


PS: Wir werden so oder sehen was auf uns kommt  

Calypte Biomedical Notified by the American Stock Exchange
PLEASANTON, Calif., June 24 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) announced today that on June 22, 2005, it received a letter from the American Stock Exchange (the "Amex") notifying the Company that it is not in compliance with certain of the Amex's continued listing standards set forth in the Amex's Company Guide. Specifically, the AMEX noted that the Company is not in compliance with Section 1003(a)(i) with shareholders' equity of less than $2,000,000 and losses from continuing operations and/or net losses in two out of its three most recent fiscal years; Section 1003(a)(ii) with shareholders' equity of less than $4,000,000 and losses from continuing operations and/or net losses in three out of its four most recent fiscal years; and Section 1003(a)(iii) with shareholders' equity of less than $6,000,000 and losses from continuing operations and/or net losses in its five most recent fiscal years.

In order to maintain listing of its common stock on the Amex, the Company must submit a plan by July 22, 2005, advising the Amex of the action it has taken, or will take, to bring it into compliance with the continued listing standards of Section 1003(a)(i-iii) of the Amex Company Guide within a maximum of 18 months of receipt of the notification letter. If the Amex accepts the plan, the Company may be able to continue its listing during the plan period, during which time it will be subject to periodic review to determine whether it is making progress consistent with the plan. If the Company is not in compliance with the continued listing standards at the conclusion of the plan period, or does not make progress consistent with the plan during the plan period, the Amex may initiate delisting proceedings as appropriate. If the Company submits a plan that is not accepted by the Amex, the Company may be subject to delisting proceedings.

The Company is currently analyzing specific actions which it may take in response to the Amex's notification letter and intends to submit a plan to the Amex.

About Calypte Biomedical:

Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.

Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB/A (No. 1) for the year ended December 31, 2004 and its subsequent filings with the SEC.

   http://www.calypte.com

    Company Contact:                   Investor Relations Contact:
    Richard Brounstein, EVP and CFO    Tim Clemensen,
    Phone: (925) 730-7200              Rubenstein Investor Relations
    email: rbrounstein@calypte.com     Phone: (212) 843-9337
                                       email: tclemensen@rubensteinir.com

SOURCE  Calypte Biomedical Corporation
   -0-                             06/24/2005
   /CONTACT:  Richard Brounstein, EVP and CFO, +1-925-730-7200 or
rbrounstein@calypte.com; or Investors: Tim Clemensen of Rubenstein Investor
Relations, +1-212-843-9337 or tclemensen@rubensteinir.com for Calypte
Biomedical Corporation/
   /Web site:  http://www.calypte.com//
   (HIV)

CO:  Calypte Biomedical Corporation
ST:  California
IN:  MTC HEA BIO
SU:

KO
-- NYF068 --
4130 06/24/2005 17:25 EDT http://www.prnewswire.com


Gruß

C.O  

was bedeutet das nun?

 

Weitere Kostenreduzierung. So ein AMEX-Listing kostet nur Geld und bringt nix.


Never argue with an idiot -- they drag you down to their level, then beat you with experience.  

Caly hat gewisse Auflagen der AMEX Vorschriften nicht einhalten können . Die haben eine so genannte Verwarnung bekommen von der AMEX und sollen bis 22 Juli ein Plan vorlegen..

Es wird schon keine Angst...

Gruß

C.O  

sei gegrüßt, steckt in deinem Posting eine gewisse Ironie oder irre ich !!!

Warten wirs mal ab, es besteht immer ein Fünkchen Hoffnung !!!

Mich hats eh gewundert, dass Caly schon 2004 an die AMEX ging, 2006 hätte gelangt, denn da gibts, wenn überhaupt das große Geld !!!

Gruß werweiß  

2006 auf jeden fall dabei + 18 Mon an der AMEX ...

Das werden die auch da bin Ich mir sicher ..

Allein der Maxim deal würde reichen ....


; )

Gruß

C.O  

Here is the Calypte plan to get the stock back up for AMEX:

1. Announce a celebrity spokesperson will be joining the company and its board of directors and going with the chairman to Wall Street to meet with investors.

2. Find a "mysterious" and "interesting" investor from overseas who will buy stock at a "lock up" price.

3. Announce that WHO approval os Calypte's test is imminent as they have waived the second part of testing.

4. Announce that rapid urine FDA IDE will be filed within 6 months.

5. Announce a multimillion dollar letter of intent to purchase Calypte's tests from a third world country. Bogus OK.

6. State that cash burn has been significantly reduced. Say it is now about 1/3 of what it actually is.

7. Make "minor" errors on outstanding shares and cash in bank figures.( 50 million and 1 million OK)

8. Project 23-25 million (and 5 million in profit)in new sales based on a "backlog" of orders that doesn't exist.

Well hey it worked 2 years ago, why not now.


Never argue with an idiot -- they drag you down to their level, then beat you with experience.  

http://ragingbull.lycos.com/mboard/boards.cgi?board=CYPT&read=67616


Diese Roy the Toy anhänger muhahaha


Ich weiß es nicht

Gruß

C.O