Replies to post #54893 on Biotech Values

[zipjet]

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

We don't have much to go on. As far as we know FDA has NOT yet spoken to the issue directly though in theory they have admitted that clinical trails are not always required.

My guess is that FDA wants a clinical trial - call it 90%. If they could come to an agreement with FDA as to what they want, it should not be a long trial since it appears they can focus on immunogenicity. Still it is going to be at least a year if a clinical is required.

I would also say there is some chance that Sandoz will sue FDA - call it 20%.

zip

[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