Biotech Values

[poorgradstudent]

The Ariad situation with the survival data will be interesting in that the investment community appears to be of the position that a lack of benefit will doom the application.

Obviously the survival data showing that rida harms would be a deal breaker, but I've been unable to get a good bearing on what are acceptable results. From an FDA point of view, there is an SPA issue (although TFCDWIW: the FDA can do whatever it wants) as well as the fact that the survival data are now being accumulated in an open-label fashion.

I know Dew threw around the HR ~ 0.85 threshold (if i remember correctly). At first glance that sounds reasonable, but I wonder if the FDA will necessitate a higher mental threshold just due to the open label nature of the study.

I'm not sure that there is any reason to be jazzed up about ponatinib at ASCO. The trial is ongoing and you're not going to get any concrete data. It'll just be a time for those who strain to find nuance in Harvey's voice, breathing and words per minute usage.