Replies to post #85768 on Biotech Values

[DewDiligence]

This just doesn't sound right to me. I have to assume that a 505b2 [NDA] would include substantial information not in a 505[j]. I doubt the FDA could switch paths w/o some serious discussions and requests for info from the sponsor.

Yes, of course. Why do you find it implausible that Teva could have furnished—or intends to furnish—such information?

c) The FDA is contemplating an ad-hoc 'in-betweener' that could be neither of the standard paths.

The 505b2 pathway is an “in-betweener” — that’s the whole point of its existence.