Replies to post #78062 on Biotech Values

[DewDiligence]

MNTA's potential will only be realized over time, if other ANDA's get turned down.

I agree. If the FDA approves the Lovenox ANDA from NVS/MNTA and fails to act on the ANDA’s from Teva and Amphastar, there will be some lingering doubt as to whether the FDA intends to approve the other ANDA’s. Hence, MNTA’s share price immediately following such an FDA announcement should logically stop short of the best-case number I posited in #msg-37875396.

What determines which ANDA's get complete examination and final word first?

There are no statutory guidelines on this—in other words, the FDA can act on the various ANDA’s in whatever order it pleases.

What are the chances that MNTA hears back first from the FDA?

I don’t know. All we have to go on is a modest clue that the ANDA from Amphastar will not be approved, as discussed in #msg-33858393. Regards, Dew