Replies to post #85767 on Biotech Values

[exwannabe]

Re: (MNTA)/TEVA labeling issue

This just doesn't sound right to me. I have to assume that a 505b2 would include substantial information not in a 505.

I doubt the FDA could switch paths w/o some serious discussions and requests for info from the sponsor.

So either:

A) TEVA is understating the issue.
B) TEVA was overstating an FDA mild query.
C) The FDA is contemplating an ad-hoc 'inbetweener' that could be neither of the standard paths.

I do agree that MNTA would have to disclose if the FDA was talking to them along the lines of going with a 505b2 for them.