Replies to post #111605 on Biotech Values

[acgood]

But then the next question is, would Lupenox meet the "chemical sameness" criteria?

[biomaven0]

The five criteria for approval set forth in the FDA’s response to SNY’s CP were not even codified in Nov 2007

I wondered about the timing too. But I figured we don't actually know when these five criteria were first communicated to the applicants rather than when they were first published. These particular five criteria are unique to enox and aren't a "generic" definition of sameness.

Peter