Biotech Values

[bladerunner1717]

Rockrat,

If I'm interpreting SNY's complaint correctly, then they are saying that the FDA, by requiring the immunogenicity data, had to compare that data to the (proprietary) data in SNY's original NDA data package, and therefore the generic applicant's application relies on (SNY's) confidential commerical information. In Mouton's previous posting, you'll see that the FDA explicitly acknowledges that they compared, i.e, did a "comparative assessment...for potential impurities that may have an adverse impact..." I believe that SNY is arguing that this kind of "comparative assessment" is prohibited by FDA statutes.

You may not agree with SNY's reasoning here, but, I believe, that's the gist of their argument.



Bladerunner