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Farmas USA

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Farmas USA
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#74849

Re: Farmas USA

AMRN. Jeje, 100 miseros cromos (no han sido míos). A ver hoy como sigue el trilerismo ilustrado.

#74851

Re: Farmas USA

Rescato la parte de la entrevista que tiene que ver con NVAX. No tiene desperdicio.

http://www.thelifesciencesreport.com/pub/na/16760#.Vfm5hTBiFoQ.twitter

 

"TLSR: Could we hear one more name?


JM: I'd like to go back to Novavax, which is a platform vaccine technology company. The vast majority of companies in biotech are drug-based, but vaccines are a unique component of the pharmaceutical world, and we see a very large potential opportunity here.

The big event for Novavax occurred back on Aug. 10, with the release of the Phase 2 respiratory syncytial virus [RSV] data from the company's RSV-F vaccine in the elderly. This was a 1,600-patient trial, and it achieved every primary and secondary endpoint, including immunogenicity. Also, the rate of RSV infection or attack was 4.9%, which is going to be key to designing the pivotal Phase 3 study that the company is preparing to initiate in Q4/15.

This is the first time anyone has been able to show protection against RSV in any patient population, let alone the elderly, who are believed to be roughly twice as hard to immunize as, say, pregnant women, which is the next Phase 2 data set we have coming in RSV. What makes this compelling is that, to date, there have been no vaccines approved for RSV. The only drug we have is a preventive antibody called Synagis (palivizumab), which was developed by MedImmune (a unit of AstraZeneca Plc (NYSE:AZN)) for a subset of patients, premature infants, who are at high risk for RSV. Synagis has become a billion-dollar drug despite such a small market.

TLSR: John, margins are normally squeezed down to nothing on immunizations, but given that this would be a unique product, at least for the time being, how much could the RSV immunization be worth?

JM: We believe this RSV vaccine opportunity could be as large as the influenza immunization market is today-a $4B market opportunity. That's huge, given there is little or no premium pricing for flu vaccines because they are equal and competitive. An RSV vaccine would be unique, and would therefore command a premium. This is a tremendous opportunity.

TLSR: Where is the maternal immunization program in the company's timeline?

JM: We will see more data in pregnant women later this month. What we're looking for here is always safety, but also the antibody levels. Given that pregnant women are easier to get an immune response from relative to the elderly, we have a high level of confidence that Novavax will be able to deliver positive RSV data there. RSV is a seasonal disease, like the flu, and it looks like things are aligning such that the company would be able to start its Phase 3 pivotal trial in RSV in the Northern Hemisphere in Q3/15, which would allow it to have data, maybe, next year.

TLSR: Looking at the clinical-stage pipeline at Novavax, I'm noting immunization programs in seasonal flu, pandemic flu and Ebola virus disease. Could you briefly comment on these?

JM: Novavax has put out some excellent flu vaccine data. Historically, this company has been known for its government contracts with the Biomedical Advanced Research and Development Authority [BARDA], which has provided Novavax with more than $150M to date. The company is eligible for another $100M for seasonal and pandemic flu programs. It had some very good success developing a vaccine against the avian flu; the most important aspect was that it was able to do it in 30 days. The World Health Organization put out a gene sequence to the world's vaccine developers, and Novavax was the first to develop it.

Novavax not only has a very powerful technology, but it is also very quick, and looks like it could address emergent threats like the avian flu, where time is of the essence. The company did the same thing for Ebola, developing a working vaccine in just 30 days and testing it within 90 days. We've had some very positive human data to date. One of the unique components is that it is the only vaccine that targets the current strain of Ebola as well as the previous strain. We think Novavax has a very powerful vaccine platform.

TLSR: John, Novavax is a $2.7B company, and its valuation has more than doubled over the last 12 months. What would you say to investors who believe this company's valuation is currently pretty rich?

JM: The first thing is that the company's pipeline of immunizations is made up of wholly owned assets. With good Phase 2 proof-of-concept data in RSV, we have a truly disruptive technology. This is a multibillion-dollar vaccine to prevent something for which nothing is currently available. The pharmaceutical industry has been trying to tackle RSV for years. Novavax, which was a smaller company not that many years ago, is now the world's leading vaccine company in the RSV space.

TLSR: Given the morbidity we see in the elderly with RSV, would you expect the Centers for Medicare and Medicaid Services to approve this immunization immediately?

JM: Yes, certainly. And we are looking at a premium of maybe $50 or $100, on top of a $50 vaccine. The company has already been putting out data on the pharmacoeconomics. It's not just morbidity; there are also mortalities and hospitalization costs associated with RSV, particularly in the elderly.

The vaccine would also prevent extended hospitalizations in "preemies." These hospitalizations are running into tens or hundreds of thousands of dollars. We've always known vaccines are basically the cheapest way to deliver medicine.

TLSR: What is your target price on Novavax?

JM: We just raised our buy limit to $15/share and our target price to $20/share.

TLSR: Thank you, John. Thank you, Jay."

 

NVAX

#74853

Re: Farmas USA

NVAX Que bonito pinta todo, como algo salga mal (que puede pasar, estamos donde estamos) me va a estar escociendo un tiempo...
Pero aquí aguantaremos como campeones

#74854

Re: Farmas USA

como algo salga mal, que ya solo puede ser en estos momentos UNA sola cosa, mamporro directo a los 6-7$ + un extra de frenada ponte a pensar en los 5$ ... y a la espera del proximo verano ...

 

NVAX

 

edito : una cosa son las valoraciones justas y otra lo que irracionalmente castigue el mercado, el mercado es soberano.

#74855

Re: Farmas USA

NVAX pues si llega ahí recompraremos, no??? Jajajaja

#74856

Re: Farmas USA

Al ser la de mujeres embarazadas , en caso de fallar , se pondria en tela de juicio la fase 1 para infantes en ejecucion. Y ya sabes que cuando el mercado duda ... castiga de lo lindo.

Yo al primer fallo , me como el premarket que sea y largaria todo, por supuesto.

Pero dados los excelentes resultados de niveles de anticuerpos presentados en la fase 2 de mujeres en edad fertil ... bueno, podria decirse que incluso perdiendo la mitad de esos niveles de anticuerpos aun dariamos sopas con hondas al mercado. Fueron demasiado buenos como para no tener en cuenta ahora una alta probabilidad de exito. De hecho, como apunte adicional, no olvidemos el fast track, the one and only fast track otorgado por la FDA para este asunto. Que estamos hablando de embarazadas con sus babies ... eso es asunto altamente delicado y la FDA demostro su confianza. 

 

NVAX

 

edito: pues eso, que me estoy pensando en liquidar todos mis metesacas y cargar mas de NVAX antes de que finalice la semana ... me lo esta pidiendo el cuerpo a gritos, las entrañas tb .... la cabeza, una parte de ella, la vinculada al instinto de supervivencia me dice que me este quieto cagüen sos ...