Farmas USA

ADXS, chicos... Me da que se espabila otra vez para las opciones.

En mi caso mi apuesta entre ADXS y NVAX, ha sido NVAX, y de momento gana por goleada ADXS, a ver si se contagia NVAX que parece metida en un bucle sin salida . Enhorabuena va los que seguís en ADXS y ánimo y paciencia a los que estamos en NVAX😉

ADXS

Pues vuelvo a mis orígenes.. Un valor en el que me siento muy cómodo y en el que confío.. A verlas venir a partir de ahora, con tranquilidad, sin pensar en demasiados valores... Todo concentrado en esta y en XOMA, nada más... salvo dos minucias en ISCO y CYTX...

EDITO: Entré en 11,83

tu como yo, lo de diversificar es para los que no tienen las ideas claras, no ? ja,ja 

La diversificación no me ha traído cosas buenas, la verdad.. La concentración, sí.. así que después de hacer experimentos fallidos, y creo que con muy mala suerte, porque la gran mayoría fueron buenas opciones, te hago caso en el sentido de parar con este valor esencialmente... Mucho menos estrés, más tranquilidad, y a verlas crecer, como las lechugas...

Dejate de colonoscopias, vino, carne y que sea lo que tenga que ser.
Ocat
Todo igual a la espera de financiación, mientras lateral 3-4.8

Kiyo me acaba de pasar esto, gracias compañero!!!

NOTA DE PIPER JAFFRAYS - 22 OCTUBRE

CONCLUSION

Novavax has initiated a follow-on Phase II RSV trial in elderly subjects. The trial will enroll the same subjects who participated in the previous, successful trial. The new trial will again dose patients with either 135ug RSV F or placebo with the endpoints being safety and the standard measures of immunogenicity. Key to the new trial is that patients will be re-reandomized, allowing Novavax to compare subjects vaccinated in sequential years, and those switching from placebo to vaccine (and vice versa) to placebo. We continue to await the initiation of the Phase III RSV F trial in elderly subjects later this year, which would could lead to pivotal data in 2H:16, approval in 2017 and sales of $1.2 billion by 2022. We reiterate our Overweight rating and $15 target.

• Phase II Follow on Adds Granularity. In its new Phase II trial, Novavax will get more detail bout how RSV-F performs in "real world" situations. Novavax is seeking to enroll the same 1,600 elderly subjects who participated in its recent successful Phase II trial. These subjects will be re-randomized to receive either 135ug RSV F or placebo. Therefore, some patients will be receiving a second sequential course of vaccine or placebo, while some patients will be switching from placebo to vaccine and others from vaccine to placebo. The primary endpoint will again be safety and antiF antibodies while PCA and microneutralization titers will be secondary endpoints. These groups should give the company a better idea about the vaccine's efficacy and safety as patients might actually use it.

• First Elderly RSV Phase II Trial Impressed. The first Phase II study of Novavax's RSV-F vaccine in the elderly showed reductions in symptomatic RSV disease by -44% (p<0.05), lower respiratory tract infections by -46% (p=0.03), and a significant -64% reduction in "more severe illnesses." The immune response was both rapid and durable pointing to a seasonal immunization. Critically, the vaccine's safety profile was comparable to placebo. Novavax is moving quickly to hold an end of Phase II meeting with the FDA with the goal of initiating a single 8-10,000 elderly subject Phase III RESOLVE trial by YE:15. This could lead to pivotal data in 2H:16, approval in 2017 and sales of $1.2 billion by 2022.

RISKS TO ACHIEVEMENT OF PRICE TARGET

Novavax's vaccines may fail in the clinic or to gain regulatory approval. The BARDA contract may falter and Novavax may require additional funds.

COMPANY DESCRIPTION

Novavax is developing next generation vaccines.

NVAX