Replies to post #180893 on Biotech Values

[mcbio]

I was looking at a company PR in which they said that the results of a Phase II trial is part of their discussions with the FDA to obtain approval [bold mine] to conduct a Phase III trial.

Question: I thought that no approval is necessary; if a company wants to do it, no matter what the Phase II results, they can.

I'm not sure that there is formal approval required. There is usually an end of Phase 2 meeting with the FDA I think just 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. Someone correct me if I'm wrong on that.

[oc631]

I was looking at a company PR in which they said that the results of a Phase II trial is part of their discussions with the FDA to obtain approval [bold mine] to conduct a Phase III trial.

Was there mention within the company PR of a SPA?