Biotech Values

[exwannabe]

Heck, even CRIS/RHHBY got pushed through with a small 100 pt open-label Phase 2 in mBCC, aBCC. Certainly not unheard of, if they target a specific unmet pt population.

Yes, Everidge was approved on a small single arm trial. But the endpoint was ORR, not PFS.

Dr Garren is claiming a single arm PFS endpoint would work.

What would an FDA stat guy consider a good PFS value in a single arm trial? I would really love to hear a rational answer on that.

My answer is none. The FDA will not accept PFS single arm, period.