Replies to post #109491 on Biotech Values

[iwfal]

many of our insights were taken into consideration by the FDA as they established their equivalence standards.

That is, or course, a post facto assertion by MNTA and without a lot of detail. I was hoping there was a prospective discussion by MNTA at some level of detail akin to the 5 items listed by the FDA. It would better calibrate 'how much' the FDA ingested and would provide better calibration going forward for Copaxone. I realize it might not take the form of a concise list of "5 items" - but, for instance, a presented paper resulting from the contaminated heparin work might have shown some of this. But I can find no such prospective detailed data.