MANNKIND - 2013 endlich zum Überflieger?

das sieht gut aus, jemand deckt sich da ein  

met primary endpoints
Bridged safety data between medtone and dreamboat as requested by fda
safe and effective
met secondary endpoint

na dann hoffen wir mal auf ein positives Voting nächste Woche  

Letzte 6,5h Handelstag vor Adcom Sitzung....Ich denke heute geht es los....

Bitte lest euch in den US Special-Boards für Pharmaindustrie ein:

http://mannkind.freeforums.net/thread/498/adcom-docs-posted

http://mnkd.proboards.com/thread/568/briefing-docs?page=7

Für Diabetes 2 sichere Zulassung für Diabetes 1 eher mit Einschränkung.

Ich schätze die Aktie wird heute schon hochschießen und nach positivem Adcom am Mittwoch durchaus auf 15-18 $.

Am 15.4. wenn FDA die Freigabe macht gibt es keine Mannkind mehr unter 20$ schätze ich.

Alles Angstmacherei von den großen online Newspaper, das sogar einige positiv gestimmte wie Nates Notes hat seine positive Haltung von gestern auf der Internetseite gesperrt ( https://www.notwallstreet.com/about-nates-notes/ ). Seeking Alpha Jeff Eisemann fasst zusammen und sagt Afrezza wird freigegeben: http://seekingalpha.com/article/...ezza-implications-for-fda-approval

Bin heute auf den Handelstag gespannt die haben nur 6,5 h und die großen wollen sich noch einkaufen!

Morgen wird die Aktie ausgesetzt wegen der Adcom Sitzung.

Am Mittwoch sollte Mannkind spätestens einen Shortsqueeze bekommen mit 63 Mil. Shorts.

Viel Glück allen investierten!  

Nates Notes Seite mit positivem Bericht freigeschalten!

https://www.notwallstreet.com/...ptimistic-ahead-adcom-meeting-32914/

Viel  Glück allen Investierten!
 

Morgen, April fool! Mal gucken was will in der Nacht passieren. Eine Zulassung ist der erste Schritt (hoffentlich).  

Was der xxxxte IPO in 2012 nicht 2 dollar? Es ist immer noch 100% Gewinn!  

wird nicht müde Mannkind schlechtzureden...er sieht sich sogar bemüßigt einen live-Blog
von der Panelsitzung morgen über Stunden zu schalten...ich hoffe so, dass er mal wieder auf die Schnauze fliegt, dieser besserwisserische Schreiberling...
 

Adam Feuerstein hat seinen negative Haltung als Fehler eingestuft und sieht "Afrezza" Diabetes Innovation von Mannkind als Sieger bei der Adcom....weisst aber auf weitere Bash Versuche von Shortern hin....  

Das AdCom hat für Typ-I Diabetes soeben 13 zu 1 mit "Ja" gestimmt, also für die Zulassung. Für Typ-II wird die Entscheidung in wenigen Augenblicken fallen.  

14:0. Also sehr gut.  

wie von vielen gewünscht. Prost!  

Al is the man, congratulations all longs, include me!
I am so proud and hate the fucking bahsers.......
 

Gamechanger in Sachen Diabetik, big pharma ist mit double Digits dabei, Milliardenmarkt,

13:1, 14:0, mehr sog I ned!

Wia geillllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll­lllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll­llllllllllll!  

...dank dir noch mehr Shortpositionen hier am Start...
und die werden brennen die nächsten Wochen...bei 10$ ...dann bei bei 20$ und dann bei
Verpartnerung bei XX$...!!!  

Nach der gestern positiven verlaufenen Adcom Sitzung für die Mannkind "Afrezza" Diabetes Medizin, sollten heute einige Deckel wegfliegen......

Wenn die Shorties sich in den letzten 2 Tagen nicht ausreichend eindecken konnten als der Kurs von knapp 6$ auf 4$ runterging und die Short Werte noch bei ca. 63 Mio liegt, gibt es hier ein noch nie gesehenes Feuerwerk!

Viel Glück an Alle investierten!    

MNKD's Insulin Produkt muss sich noch viel zeigen. Eine Partnerschaft mit einer großen Konzern wird wirklich schön sein! Vielleicht haben die großen die Zulassung dieses Produktes verzögert? Warten wir es erstmal ab. Ich werde ordentlich nachlegen bei einer Partnerschaft.  

http://us.rd.yahoo.com/finance/external/tsmfe/...hoo&cm_ven=YAHOO  

Wow, testimonials vom glorreichem Adcom:

https://www.youtube.com/watch?v=ylin1ZSDo0o  

Es ist aber ruhig geworden hier!
Na ja, die Applikation von Insulin über die Lunge sehe ich auch nicht als die Zukunft der Therapie.
Da gibt es interessantere Ansätze, z.B. die orale Gabe. Tabletten sind für Patienten immer die am Einfachsten zu handhabende Möglichkeit.

Wen es interessiert, Oramed ist aktiv, neben Novo Nordisk, die spielen natürlich auch mit.  

Du hast keine Ahnung von Afrezza, es wirkt in 12-15 Minuten anstatt 45-90 Minuten und bleibt nur 2 Stunden im Körper, anstatt ca. 5 Stunden, Ultra-Rapid-Actin Insulin!

Das ist das einzige ultra schnell wirkende Insulin weltweit und kann diskret überall mit dem winzigen pfeiffengroßen Inhalator ohne Kühlung eingenommen werden!

Gamechanger in Sachen Diabetik, darum das FDA Adcom von 13:1 und 14:0 zugunsten Afrezza!  

General Investing MannKind Corporation (MNKD) Considers Entering Pain Management Market May 06, 2014 MannKind Corporation (MNKD) COO Hakan Edstrom says his company is “looking closely” at expansion opportunities in the pain management market. “If you get the medication into the bloodstream very quickly, you also have a relief of the pain much, much quicker. There are also nonopioid opportunities, where you may even be able to treat patients for their pain without having the risk of them getting into situations where they are dependent on the drug itself because of the side effects,” Edstrom says. “That’s one area that we are looking into right now, and there are some others that I, unfortunately for proprietary reasons, cannot necessarily speak on at this point in time.” FOR MORE INFORMATION ON THIS INTERVIEW CLICK HERE. Edstrom says MannKind is still in the preclinical phase of its pain management research. He says the company has conducted feasibility studies, but not yet moved on to subsequent phases of research. “We have had to manage our resources because AFREZZA has been such a major undertaking for the company,” Edstrom says. “We’ve had to be a little bit more conservative in the investment in other areas until we feel that we have a successful product on the market and a partnership, which is what we’re looking to with AFREZZA.” - See more at: http://www.twst.com/news/...ring-pain-management#sthash.q8flyG1L.dpuf  

MannKind Corporation Earnings: Are Better Times Ahead?

By Dan Caplinger  | More Articles  | Save For Later
May 10, 2014 | Comments (0)  


On Monday, MannKind  (NASDAQ: MNKD  ) will release its quarterly report, and investors don't expect any immediate positive results from the clinical-stage biotechnology company. The company has been waiting for a long time for FDA approval of its Afrezza inhaled insulin product, but established insulin producers Eli Lilly  (NYSE: LLY  ) and Novo Nordisk  (NYSE: NVO  ) are working hard to protect their competitive advantage, and it's still unclear whether MannKind will convince the FDA that any safety issues with Afrezza are less substantial than the potential benefits.

Dealing with insulin is a big hassle for patients suffering with diabetes, as the need for injections is at best a chore and at worst can cause complications for diabetics. The promise of an inhalable insulin product is attractive to many diabetes sufferers, and that has driven interest in MannKind for years. Yet investors are impatient for FDA approval to see just how big the opportunity will be for MannKind, especially in light of potential competition. Let's take an early look at what's been happening with MannKind over the past quarter and what we're likely to see in its report.


Dreamboat (2nd generation) inhaler. Source: MannKind.

Stats on MannKind



Analyst EPS Estimate

($0.13)


Year-Ago EPS

($0.15)


Revenue Estimate

$0


Year-Ago Revenue

$0


Earnings Beats in Past 4 Quarters

0


Source: Yahoo! Finance.

Will MannKind earnings ever appear?
With MannKind earning no revenue, analyst earnings projections all hinge on how much they expect the company to spend. Those loss projections have risen recently, with first-quarter loss estimates widening 30% and full-year 2014 loss projections widening by 40%. Yet the stock is up 22% since early February.

MannKind's fourth-quarter financial report didn't hold any big surprises for investors. Operating expenses rose 39%, with the rise coming largely from stock-based compensation charges. Losses per share fell, but only because the number of shares MannKind had outstanding rose dramatically.

The key event for MannKind during the quarter, though, came in April, when an FDA advisory committee recommended that Afrezza be approved, with a unanimous 14-0 vote for type 2 diabetes and by 13-1 for type 1 diabetes. That news was especially welcome because of a scare among investors when the advisory panel presented its briefing materials, which indicated that MannKind had thrown some curveballs at the FDA.

Unfortunately, MannKind investors haven't gotten everything they wanted, as the FDA announced that it would delay its full approval decision beyond its initial April 15 deadline. Yet even though some investors got nervous about the delay, the fact that the deadline fell so close to the date on which the advisory panel made its recommendation is a good reason for the FDA to give itself more time to evaluate briefing materials and make a more considered decision.

One essential aspect of MannKind's future is whether it will find a partner for distributing Afrezza if it gains FDA approval. Because Eli Lilly and Novo Nordisk compete directly against Afrezza with insulin products of their own, MannKind will likely have to look elsewhere for potential partners. Yet with some other major pharmaceutical companies looking to ramp up their exposure to the diabetes space, MannKind should find little trouble gaining interest -- as long as the product gets approved.

In the MannKind earnings report, investors will want to listen for whether the company has made progress in finding a partner. For the most part, though, investors simply have to wait and see what the FDA has to say before MannKind can come up with a strategy for making the most of the Afrezza opportunity.



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Dan Caplinger and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
 


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Dan Caplinger
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Dan Caplinger has been a contract writer for the Motley Fool since 2006. As the Fool's Director of Investment Planning, Dan oversees much of the personal-finance and investment-planning content published daily on Fool.com. With a background as an estate-planning attorney and independent financial consultant, Dan's articles are based on more than 20 years of experience from all angles of the financial world.  
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http://seekingalpha.com/article/...ve-as-investors-await-fda-decision  

Hat sich schon mal jemand Gedanken zu einem möglichen Kursziel nach FDA-Zulassung und Partnerfindung gemacht?

Was ist machbar?  

Denke 12-14 $ sind nach Approval und Partner möglich