Biotech Values

[zipjet]

>> I don't think mnta will have refiled in that time frame. So that rules out a couple of scenarios.

Considering the running nature of an ANDA, why are we at a point that they need to refile? (I am NOT asking if we are at that point.) Is this a way of FDA getting another filing fee? Or do they just want to a "disposition" of a filing for statistical purposes? Or could they be saying that they are never going to approve?

Yet neither TEVA nor Amphastar, with the same need for data on immunogenicity, so far as we know have NOT received a not approvable designation.

ij