Aveo Pharmaceuticals Next Hit ?

wer wollte denn da unbedingt um 8 Uhr mit 2,89 rein???
LG
Gaertner  

... mit quasi null Umsatz kaufen zu wollen ...GRINS  

FOR NEW (& existing) INVESTORS, HERE ARE SOME OF MY THOUGHTS & FACTS I RESEARCHED:
 

https://investorshub.advfn.com/boards/...sg.aspx?message_id=132876049  

... selbst ich raus !
Wenn' s einmal erst zu fallen angefangen hat, nun ja, man kennt das ja ...
Abkühlung bis weit unter 2 Dollar ist hier dringend angebracht !  

Kursziele?

War dabei schon die CHMP entscheidung eingepreist?

Langfristig sieht das ja mit der CHMP Entscheidung besser aus - klar gibt ab und an auch mal Kursrücksetzer, aber die Entscheidung des CHMP ist schon ein Meilenstein der nicht unbeachtenswert ist.

lg  

Bin langfristig drinne und hab im Chart nur einmal über 2 Euro gesehen, da war aber nichts mit CHMP wenn ich das richtig gelesen hab - oder?

Bin noch nicht so lange hier.  

... hier raus.  

ist das wichtigste ab warten  

 

...Ketullt issd angesackt hir,   sicha  noch 10 Johre !
Letz Koo !!!  

http://www.ema.europa.eu/docs/en_GB/...Agenda/2017/07/WC500231582.pdf

Unter B.4. EPARs/WPARs (Seite 39):

 

EPAR
Der European Public Assessment Report wird von der Europäischen Arzneimittelagentur EMA für jedes für ein zentrales Zulassungsverfahren eingereichtes Arzneimittel für die Human- oder Veterinärmedizin erstellt und veröffentlicht. Kernstück ist die wissenschaftliche Diskussion, in welcher das Nutzen-Risiko-Verhältnis umfassend abgewogen wird. Sie schließt mit einer positiven oder negativen Empfehlung (positive/negative opinion) des Ausschusses, auf die sich die Erteilung oder Ablehnung der Arzneimittelzulassung durch die Europäische Kommission gründet.[1]

Quelle: Wikipedia

Weitere Informationen von der europäischen Arzneimittelagentur:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/...ntent_000433.jsp

 

25 von 30 Stimmen für Positiv!!!

Seite 12 Minutes of the CHMP meeting 19-22.06.2017

3.1.2. Fotivda - tivozanib - EMEA/H/C/004131

EUSA PHARMA; treatment of adult patients with advanced renal cell carcinoma (RCC) Scope: Opinion
Action: For adoption
New active substance (Article 8(3) of Directive No 2001/83/EC)

List of Outstanding Issues adopted on 26.01.2017. List of Questions adopted on 21.07.2016.

The Committee confirmed that all issues previously identified in this application had been addressed.

The Committee adopted a positive opinion recommending the granting of a marketing authorisation by majority (25 positive out of 30 votes) together with the CHMP assessment report and translation timetable.

Furthermore, the CHMP considered that tivozanib hydrochloride monohydrate is a new active substance, as claimed by the applicant.

The Icelandic Member was in agreement with the CHMP recommendation and the Norwegian Member was not.

The divergent position (Agnes Gyurasics, Alar Irs, Bruno Sepodes, Johann Lodewijk Hillege, Sinan B. Sarac, Svein Rune Andersen) was appended to the opinion.

The legal status was agreed as medicinal product subject to medical prescription. The summary of opinion was circulated for information.
The CHMP adopted the assessment report on similarity. 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/...0b01ac058004d5c3

 

die 3 euro angekratzt....
 

oder wie man früher zu sagen pflegte:
die gehn wech wie warme Semmeln....
oder wars geschnitten Brot???  

http://ec.europa.eu/transparency/regdoc/...Order=DESC&language=de

 

AVEO Oncology Announces FOTIVDA® (tivozanib) Approved in the European Union for the Treatment of Advanced Renal Cell Carcinoma ​

http://www.aveooncology.com/wp-content/uploads/...ozanib-Approval.pdf

 

The European Medicines Agency has cleared once-daily VEGF inhibitor tivozanib under the Fotivda brand name as a front-line treatment in adult RCC patients. That means it can be used in patients whose disease has progressed one line of cytokine therapy with interleukin-2 or interferon, provided they have not previously been treated with other drugs including VEGF or mTOR inhibitors.

The EMA approval is based on the results of the TIVO-1 trial, in which tivozanib was found to be better than Bayer/Onyx's VEGF inhibitor Nexavar (sorafenib) in extending progression-free survival (PFS) with fewer side effects. The FDA thought was not up to scratch when it turned down the drug in 2013, but the EMA's advisory committee interpreted the data differently, recommending approval earlier this year.

http://www.fiercebiotech.com/biotech/...rug-tivozanib-rises-up-europe

 

Übernahme für 19 dollars.....

https://cnafinance.com/...veo-stock-gaining-big-on-buyout-rumor/16444  

AVEO Oncology Announces Receipt of Payments from EUSA Pharma and CANbridge

http://www.nasdaq.com/press-release/...a-and-canbridge-20170913-00256

 

AVEO Oncology and EUSA Pharma Announce TiNivo Combination Study Opt-in

http://www.nasdaq.com/press-release/...ion-study-optin-20170920-00292

 

AVEO Oncology Announces Completion of TIVO-3 Study Futility Analysis with No Changes to Study Protocol​

http://www.nasdaq.com/press-release/...hanges-to-study-20171005-01266

 

AVEO präsentiert nachbörslich herausragende Phase 1 Ergebnisse .


On November 3, 2017, results of AVEO’s ongoing phase 1 portion of the TiNivo study, a phase 1/2 multicenter trial of tivozanib (FOTIVDA®) in combination with Bristol-Myers Squibb’s nivolumab (OPDIVO®), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma (RCC) are being presented at the 16th International Kidney Cancer Symposium in Miami, Florida, in an oral presentation titled “TiNivo: A Phase Ib Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma” by Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study.
The phase 1 portion of the trial enrolled six patients, three with previously untreated metastatic RCC and three who had received first-line treatment. RCC tumor histology included five clear cell (one with sarcomatoid features) and one papillary. Tivozanib was administered to patients in two escalating dose cohorts (1.0 mg/QD and 1.5 mg/QD) in combination with nivolumab at a constant 240 mg every 2 weeks. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Unconfirmed best response to date includes a 67% (4/6) partial response (PR) rate and a 100% disease control rate (PR + stable disease). Enrollment of approximately 20 patients in the phase 2 portion of the trial is ongoing.
AVEO is encouraged by the promising preliminary tolerability and activity results from the TiNivo trial, and believes that they begin to underscore the unique potential of tivozanib-immunotherapy combinations. The Company expects to present the results of the phase 2 portion of the TiNivo trial in the first half of 2018, and anticipates initiating additional combination studies in the next year.  

http://www.nasdaq.com/press-release/...tinivo-study-of-20171106-00129