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Farmas USA

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Farmas USA
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#78265

Re: Farmas USA

EXEL

Para el que quiera emociones fuertes, tiene prevista respuesta de la FDA para el día 11 de noviembre:

Exelixis (NASDAQ:EXEL) is a small-cap biotech stock that might be worth adding to your portfolio in November because the company has an important regulatory catalyst during the month. Specifically, Exelixis and its partner Roche (NASDAQOTH:RHHBY) are supposed to receive the final word from the FDA by Nov. 11 on cobimetinib's regulatory application as a treatment for BRAF V600 mutation-positive advanced metastatic melanoma when used in combination with Zelboraf.

At the American Society of Clinical Oncology's annual meeting last May, Exelixis announced that this cancer-fighting combo produced a progression-free survival, or PFS, rate of 12.3 months, compared to 7.2 months for Zelboraf alone, in a pivotal late-stage study dubbed "coBRIM".

Based on this impressive trend in PFS, the EU's regulatory agency issued a favorable opinion on the co-therapy that's expected to lead to a marketing approval before the end of the year. And last September, the licensing and supervisory authority of Switzerland gave the combo treatment the green light for patients with advanced melanoma. I'm thus cautiously optimistic that the FDA will approve this regulatory application.

As such, the bigger mystery at this point appears to be cobimetinib's commercial potential for this initial indication. The handful of estimates that have emerged from analysts so far suggest that peak sales could range from anywhere between $150 million to $800 million per year. The problem is that the advanced melanoma landscape is already crowded, and there are several other experimental treatments showing promise in clinical trials right now. So Exelixis and Roche's combo treatment may have trouble standing out in the crowd.

All told, I think an FDA approval for cobimetinib would go a long way toward improving the market's view of Exelixis as a viable long-term investment. And that's perhaps where the deep value of this potential regulatory approval may ultimately lie.

http://www.fool.com/investing/general/2015/11/01/3-biotech-stocks-to-buy-in-november.aspx?source=eptadnlnk0000002&utm_source=advfn&utm_medium=cpc&utm_campaign=investorshub

#78267

Re: Farmas USA

Yo esperaré a su 10Q para ver algo que en el anterior trimestre no me gustó mucho. Cuando esté listo comento, aunque si andamos igual que en Q2 no os va a gustar... Ya sabes, yo dándole caña a sus números. Aunque con no hacerme nada de caso lo tenéis arreglado :))

AMRN

#78269

Re: Farmas USA

AMRN

¿Qué quieres decir?

No te sigo.

Respecto a NVAX, INVESTING indicando que hoy son los resultados Q3... Aunque ya está comentado, son el día 9 a las 8:00 usanas.

#78271

Re: Farmas USA

EXEL

Mugui, ¿qué valoración le das?, parece interesante.

#78272

Re: Farmas USA

AMRN

Ah bueno, eso si lo sé. Pero pensaba que había un mensaje oculto en el post de Mugiwara

thanks.