Biotech Values

[10nisman]

That the FDA took five years to approve NVS/MNTA’s ANDA and has been reviewing Teva’s and Amphastar’s ANDAs for almost eight years is, IMO, prima facie evidence that the “junk” in Lovenox matters.

I agree completely that the "junk" matters. I'm just trying to understand if MNTA has set the bar that all competitors need to meet to obtain FDA approval. Basically, would the FDA approve another generic Lovenox that was of lesser quality as mLovenox?

10nis