Biotech Values

[mcbio]

RE: MNTA - generic Lovenox approval path

You cited the FDA’s comments at the time of the Omnitrope approval as precluding FDA approval of a Lovenox ANDA; however, the FDA’s comments applied to 505b2 NDA’s for protein drugs rather than to ANDA’s for heparin-based drugs such as Lovenox. Lovenox—and all of the low-molecular-weight heparins—have always been regulated by the FDA as small molecules.

Iwfal strikes me as one of the more knowledgeable posters on here. If he is confused about the approval pathway for a generic Lovenox (i.e., the fact that no new legislation is needed), I can't imagine how many other knowledgeable investors may be confused about this, let alone the multitude of less experienced investors. Perhaps this is one factor that is suppressing the share price of MNTA?