Replies to post #79499 on Biotech Values

[DewDiligence]

MNTA: If the FDA is really buying in on the exactness of Momenta’s 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?

Heparin per se has very low immunogenicity (it’s not a protein), and hence any immunogenicity that might be caused by a heparin-based drug would likely stem from impurities in the manufacturing process. Thus, the non-clinical data on immunogenicity that NVS/MNTA furnished to the FDA in Sep 2008 serves the purpose of verifying the product’s purity.

[bladerunner1717]

iwfal,

Is it possible that you science guys should consider that this is not a "science" question, but rather a "political" one?


I think it should be considered that--Dew's arguments that heparin is not a biologic notwithstanding--the FDA is looking for some kind of political cover for this approval, a cover that some form of FoB legislation might provide.

It just a thought. As usual I have no idea what I'm talking about.


Bladerunner