Biotech Values

[DewDiligence]

Re: MNTA Lovenox ANDA

What will the FDA want to satisfy the concerns about immunogenicity?

>Care to put odds on new trials for MNTA.<

I’d say the probabilities break down like this:

a) New human trial(s): 58%.

b) New animal trial(s): 26%.

c) A combination of in vitro testing, citations from peer-reviewed literature, and threats of an Omnitrope-like lawsuit: 16%.

JMHO, FWIW