Biotech Values

[DewDiligence]

EMEA Sandoz news vis-à-vis MNTA:

I saw your post on the MNTA board and I think it warrants discussion. MNTA's near-term success will be based on ANDA’s such as the one for Lovenox. When the FDA finally gets around to allowing generic biologics, I expect the regulatory process to be akin to a 505(b)(2) application rather than an ANDA. I.e., an applicant submitting a dossier for a generic biologic will presumably be able to use some historical clinical data for the corresponding branded product, but the resulting approval will not for a substitutable full-fledged generic but rather an alternate brand.

For MNTA, specifically, I see such a development as neutral rather than bullish. Regards, Dew