Farmas USA

ONVO hasta el 21 Diciembre no tiene vencimiento de opciones

no vendi APPA Y AHORA SALE Que insider compra 1,000,000 de acciones :)

Tampoco vendi IPCI.

Compre mas de BSPM Biostar Pharmaceuticals Inc (NASDAQ:BSPM) ayer, se encuentran en el puritito support, ....... tres INSIDE DAYS consecutivos y volumen ..... disminuyendo !!!........

Parece que va a superar los $3.44 (52 week high) prontito !!! manana truena !!!!!!!

Nuevo palo para AMRN gentileza de la FDA
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Han rechazado su apelación a la rescisión del SPA y no garantizan que tenga lugar la famosa reunión para intentar salvar de alguna manera ANCHOR.
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Status update on special protocol assessment (SPA) rescission appeal.

Vascepa is currently approved for the MARINE indication. The PDUFA date for FDA’s action on Amarin’s sNDA for the ANCHOR indication is December 20, 2013. The FDA, at its discretion, could act sooner than this date. The ANCHOR study supporting the sNDA was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. On October 29, 2013, the FDA rescinded that SPA agreement and on November 7, 2013 Amarin appealed the rescission within FDA.

On November 21, 2013, Amarin received notification from the dispute resolution group of the Office of New Drugs at the FDA that it has not accepted for review, on procedural grounds, Amarin’s appeal. Amarin and the FDA have communicated on the above matters, but Amarin has not been successful to date in convincing the FDA to accept its appeal for review at a level above the review division within FDA or in convincing the FDA that the appeal of the SPA rescission is a matter sufficiently distinct from the ANCHOR sNDA to warrant separate consideration under the formal FDA appeal process. Amarin plans to continue to interact with the review division of the FDA regarding the sNDA and the SPA. Amarin believes its appeal is procedurally correct and that whether the ANCHOR SPA agreement was lawfully rescinded is a distinct legal issue (from our pending ANCHOR sNDA) that is appealable under applicable regulations and guidelines. Amarin was also notified by the FDA that Amarin’s request for a meeting at a high level within FDA regarding the appeal was not granted and that Amarin would first need to address the matter at the division level within FDA.

Amarin plans to continue to pursue the appeal of the ANCHOR SPA rescission and approval of the ANCHOR sNDA with FDA and to update investors as appropriate. There can be no assurance that Amarin will be successful in its appeal of the SPA agreement rescission or, more importantly, the approval of the ANCHOR indication sNDA

Joder, no les quieren ni escuchar porque saben que si les dejan hablar les podrian sacar los colores.
Que verguenza.

AMRN

HZNP

Pues ya sabemos el motivo de la subida. La competencia retira al solicitud de genérico a la FDA.

http://www.streetinsider.com/Corporate+News/Horizon+Pharma+%28HZNP%29+Notified+by+Par+Pharma+of+RAYOS+ANDA+Withdrawal/8917042.html?si_client=intbro

THLD
Threshold Pharmaceuticals anuncia nuevos datos clínicos sobre TH-302 y Avastin (R) (bevacizumab) en glioblastoma recurrente después de un fallo Bevacizumab

http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=809108

s2

Edito: Veo que Anaramos ya lo colgó en el hilo de THLD

Back to the hell

AMRN

$1.75* 0.239 negative 12.02%

Poco volumen, pero significativo...

AMRN