Replies to post #180898 on Biotech Values

[DewDiligence]

There is usually an end-of-Phase-2 meeting with the FDA…to get some feedback on what would constitute a successful Phase 3 study design and result. But, I don't think the FDA formally has to approve a Phase 3 start.

Correct, unless the FDA thinks the proposed phase-3 program has unacceptable safety risks.

[oldberkeley]

mcbio,dew- thanks much, just wanted to confirm that.