Replies to post #85760 on Biotech Values

[DewDiligence]

MNTA TEVA:

It implies that applications filed under one approval pathway can somehow 'drift' off into another pathway...

The change from an ANDA to a 505b2 NDA would have to be explicit and agreed to by both the sponsor (Teva) and the FDA. Teva would presumably agree to such a change if they ascertained from discussions with the FDA that their ANDA was going to be rejected.

…with no statements to that effect from either the company or the FDA?

The FDA does not comment on pending drug reviews (except in the case where an advisory panel is being convened). Teva has neither an obligation nor an incentive to disclose such a change.