Replies to post #82241 on Biotech Values

[go seek]

>So the important point is that Amphastar was sufficiently concerned about an MNTA only approval that they would take this step. And what caused them to act now (rather than earlier)?<

Good Point!

[DewDiligence]

MNTA:

The only rational reason [for Amphastar] to fire a preemptive first shot at the FDA [is] to avoid an "MNTA only" approval (since otherwise any bias would work to their benefit). So the important point is that Amphastar was sufficiently concerned about an MNTA-only approval that they would take this step. And what caused them to act now (rather than earlier)?

As previously discussed (#msg-33858393), Amphastar’s prospects to get FDA approval dimmed when the FDA did not act during Amphastar’s 180-day exclusivity period, which ended on 3/31/09. The new action by Amphastar relating to Dr. Woodcock adds to the circumstantial evidence that Amphastar’s ANDA is unlikely to be approved.