Replies to post #84508 on Biotech Values

[DewDiligence]

MNTA:

…do you think MNTA's recent cash infusion may be an indication that they think FDA response on generic Lovenox will be further out than they thought?

No—if anything, Craig Wheeler’s comments on the R&R webcast on 9/9/09 suggest that FDA approval may be closer than MNTA previously thought.

Or is it a case of "do it, when you can" mentality.

I would describe the latest financing transaction as, “Do it when you can if the terms are favorable,” which is quite different from doing it just because you can.

Is there any information regarding Teva's and Amphastar's ANDA's? I can't find anything out there. I don't know how one can gauge the extent of their ability to characterize Lovenox.

The only publicly available information on this is what’s contained in the responses Teva and Amphastar submitted to Sanofi’s Citizen Petition asking the FDA not to approve a generic Lovenox. From these responses, one can infer that Teva and Amphastar favor a low approval hurdle based on less than full characterization of the active ingredients in Lovenox.