Biotech Values

[exwannabe]

...this is not unheard of for disease with serious unmet medical need, I can think of one example. The initial SPA of ipilimumab was for a single-arm study demonstrating 10% response rate.

Yeah, response rate is OK in a single arm.

PFS (and even OS) is not because there is no way to evaluate it.

I can certainly find an example where the FDA would not even consider PFS data for exactly this reason (in a very similar setting). Can anybody name a case where a drug was approved on PFS single arm?