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Farmas USA

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Farmas USA
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Farmas USA
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#59145

Re: Farmas USA

Nvax

¿Cierre de cortos?

#59147

Re: Farmas USA

Puede ser, probable

NVAX

#59148

Re: Farmas USA

"Anticipate 1st of many partnerships outside of U.S"

AMRN

#59149

Re: Farmas USA

Arena says Belviq refiling in Europe should occur by Q1 2016 • 4:55 PM

Douglas W. House, SA News Ed...
  • In a regulatory filing, Arena Pharmaceuticals (NASDAQ:ARNA) discloses that it expects commercial partner Eisai to refile the Marketing Authorization Application (MAA) in Europe for its obesity drug Belviq (lorcaserin HCl) by the end of the latter's fiscal year ending March 31, 2016.
  • Arena originally submitted the Belviq MAA in March 2012. In January 2013 it received a Day 180 List of Outstanding Issues from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The major objections preventing approval pertained to non-clinical and clinical issues including tumors in rats, valvuopathy and psychiatric events. CHMP requested that the benefit-risk balance of Belviq be further justified taking these issues into consideration. After a written response to the Day 180 List and an oral presentation to CHMP failed to assuage its concerns, the company withdrew the MAA in May 2013.

ARNA

#59150

Re: Farmas USA

Framus, perdona, es que estaba haciendo otra cosa y se me ha ido el dedo.

Mañana lo arreglo comprando 5 millones, ok?

#59151

Re: Farmas USA

Buen report,creo que no podemos tener queja delos ultimos,ideas claras,camino marcado y a esperar que pase el tiempo.

Añadamosle el temas de el acuerdo en China y posibles nuevos anuncios....esto marcha :)

#59152

Re: Farmas USA

+11 en el after

mañana gap? Podria sre

AMRN

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