Replies to post #165413 on Biotech Values

[DewDiligence]

PTLA—From the same transcript:

We expect to start [the] Phase 3 program with pharmacodynamic based endpoint clinical trials of between 100 and 200 patients followed by supportive trial in patients that have either active bleeding or undergoing emergency surgery.

I.e., PTLA is calling the PD study a phase-3 and implying that the efficacy studies can be done on a post-marketing basis. As noted in my prior post, I don’t think the FDA will go for such a plan.