Biotech Values

[p3analyze]

"In hindsight, GPC probably should have taken its chances on getting a statsig outcome using the original (lower) event trigger for PFS, which would have averted the current tactical dilemma.?
Completely agree.

"Don’t you think it would be colossally embarrassing to the FDA to approve the drug in August only to rescind the approval a few months later?"

FDA has thick skins. How embarassing it is to approve despite vehment protest from FDA statisticians the Pmab knowing the hazard ratio for OS were 1.03, or Gemcitabine for ovarian (granted it was a sNDA) with a complete lack of OS difference, or for that matter to reject Provenge despite it showed statistically significant OS!?

The recent endpoint consideration document has signaled a greater willingness to use PFS as clinical benefit endpoint.