Farmas USA

Framus, ilústranos y dinos cuando romperá NVAX esa ventanita.

:( Qué faena, no recordaba que fueras tú, lo que no se me olvida es tu buena jugada en mack :) que por cierto sigue distanciándose de thld a pesar de la bajada que lleva en las últimas semanas.

Alguna buena jugada ha habido también ;-P

En Mack el Director se compra 5000 acciones todos los meses. Es su plan de ahorro para el futuro.

PBYI

We do not see significant risks for FDA approval
Results from the ExteNET trial were presented at the ASCO meeting. Although the
discussant from Memorial Sloan Kettering stated that there is no survival benefit at
this point, we do not believe the FDA will need to see survival benefit for approval in
the adjuvant setting. The primary endpoint of the ExteNET trial is invasive disease
free survival (IDFS) for the intent-to-treat population at 2 years – this will be the
basis for NDA filing and we believe for FDA approval. When Herceptin was
approved for adjuvant breast cancer indication, the FDA did not require overall
survival benefit and we expect the same with neratinib.
Commercial implications from the subgroup analysis
Subgroup analyses support use of neratinib in high risk, HR+ patients. Although the
difference in IDFS event rate was 2.3% for the overall population, treatment benefit
was more pronounced in hormone receptor positive (HR+) patients. After one year
of treatment, the difference in IDFS rate was 1.9% between neratinib and placebo
arms, which increased to 4.1% at the two year follow-up. We expect the treatment
benefit to widen with longer follow-up with HR+ patients. In contrast, the IDFS
benefit shrank from 2.6% at one year to 0.2% at two years in patients who are HR
negative. Considering roughly 50% of HER+ patients are HR+ and assuming
roughly 10%-20% of patients are high risk patients who are HR-, we continue to
believe that 60% of the adjuvant breast cancer market is addressable with neratinib
treatment.
Three year follow-up data will provide greater clarity
We expect three year follow-up results from ExteNET trial to be presented at the
San Antonio Breast Cancer Symposium (SABCS) in December. Given the recent
stock move, we believe the commercial opportunity in HR- patient population is not
reflected in shares anymore. If the IDFS benefit continues to widen versus 1-2 year
results, particularly for HR+ patients, we believe this bodes well for FDA approval
and the commercial opportunity.

Comprando a 14 es mucho pasta la que tiene que emplear.

Fold esta en 14. El director del que hablaba es el de Mack que esta en 11$

Disculpa, había visto que llego allí pero no el precio

Pbyi
Bueno,parece que la compañía se está moviendo para que salgan noticias que ayuden a subir un poco el precio. Espero que no sea la última y que continúen ka próxima semana