Replies to post #100551 on Biotech Values

[DewDiligence]

There will always be a cloud hanging over Momenta until the FDA acts one way or the other on both Teva and Amphastar.

Yes to some degree with respect to Teva, but not with respect to Amphastar because it’s clear that the Amphastar ANDA is not close to being approved. It’s unlikely, IMO, that it ever will be.

Inasmuch as Amphastar is an also-ran company with no known expertise in the characterization of complex mixtures, I fail to see why anyone would think Amphastar has what it takes to meet the requirements laid out in the FDA’s response to SNY’s Citizen Petition.