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Farmas USA

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Farmas USA
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Farmas USA
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#97179

Re: Farmas USA

Por un lado está haciendo lo esperado, moderarse una vez obtenido el poder. Por otro, el mercado puede tomarlo como un síntoma de debilidad del sector.

Igualmente debería consolidar un poco después de las subidas que vimos la semana pasada. Es lo que pienso.

#97182

Re: Farmas USA

DVAX

Pues ahí está la CRL

Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=999142

The CRL seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events. The responses included an extensive analysis that included independent expert consultation supporting our view that the imbalance was driven by an unexpectedly low number of events in the comparator arm. It would appear the Agency could not fully assess the responses in the current review period. In the CRL, there is no request for additional clinical trials and there are no apparent concerns with rare serious autoimmune events.

#97183

Re: Farmas USA

DVAX
Al foso hoy y a esperar 6 meses mas y creo anuncia que esta buscando partner
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"The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible," said Eddie Gray, chief executive officer of Dynavax. "However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner. We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma."

#97184

Re: Farmas USA

DVAX

peor, no es solo que anuncie que busque partner, es que dice que no es capaz financieramente de poder llevar heplisav hasta su aprobación sin la ayuda (pasta) de un tercero...

Pues sí, al foso.

Edito: no sé si Ana lleva el corto abierto aún, para ella el foso será el cielo! -35% en los primeros tradings