Biotech Values

[DewDiligence]

MNTA:

How do we know that the FDA won't require clinical trial data for m-enox…?

We don’t; however, we may surmise that if the FDA wanted MNTA to run a clinical trial, the FDA would already have made such a request during the 4.5 years the Lovenox ANDA has been pending.

…just like the Europeans did?

No one has submitted an application for a Lovenox knockoff in the EU, so I presume you’re referring to the EMEA’s published guidelines for heparin-based biosimilars, which have no standing with the FDA. Regards, Dew