Biotech Values

[iwfal]

MNTA - Lovenox FDA approval

the observation that assuring the integrity of the bulk-heparin supply chain appears to be the sole remaining roadblock to approval of the ANDA.

After listening to the conference call I am not sure I would phrase it that way - he said it was the only thing the FDA was currently asking about, but that the FDA has the ability/right to go back as they choose.

On a more basic question. If the FDA is really buying in on the exactness of Momentas duplication (which, per the speaker in the cc, is perfect, so that it is absurd to run an immunogenicity trial) then why did the FDA ask about immunogenicity and hold up Momenta for 2 years?

This goes to whether the FDA really believes Momenta when they say the duplication is exact. Whether the FDA is capable of ever believing that it is exact.