Replies to post #49931 on 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.

[p3analyze]

"However, GPC subsequently increased the event-count trigger for the PFS endpoint"

Seems that they increased OS counter as well - was it re-SPA'd

FDA document states " Initial estimated sample size was 912 to have 602 deaths within 36 months... It was later decided to increase the power to 90%, requiring 700 deaths"- by whom?

[p3analyze]

Has DMC mandated cross-over after the interim analysis? I noticed FDA presented the hazard ratio of 0.9 with footnote that was when placebo patients were not crossed over to Satraplatin. If cross-over did happen, then it's a blessing - just the way it did for panitumumab, wouldn't you say?