Replies to post #47547 on Biotech Values

[iwfal]

Can you show me one other time in the last 3 years where the fda approved a drug with a missed phase 3 in a non-life threatening disease.

Unfair question. Perhaps 10, but probably fewer, completely new drugs have been approved in the last 3 years that are not for life threatening conditions. The chance that one of their trials would be stat sig and one between, say, 0.05 and 0.1 is small.

But note that with looser criteria there are cases - e.g. Arixa (which was granted full approval, albeit with a required post marketing study for safety) with one stat sig and one at p=0.09 per FDA analysis.

Clark