Biotech Values

[DewDiligence]

>This is an accelerated approval - unlike provenge - it would be easy for FDA to pull the approval if OS is not significant.<

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?

>Of course if FDA really cared for the OS endpoint, it should have never allowed it to be submitted first.<

When the SPA was originally crafted, it was assumed by both parties that there would be a longer time gap between the maturing of the PFS data and the maturing of the OS data. However, GPC subsequently increased the event-count trigger for the PFS endpoint, thereby reducing the time gap between PFS reporting and OS reporting.

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.