Biotech Values

[DewDiligence]

Re: Prognostic value of FDA's Lovenox actions

Dew, do you agree with the following opinion?

No, I disagree with the opinion from Bernstein’s Tim Anderson in the write-up you cited. From your post:

The FDA's decision to make Momenta's drug fully "substitutable" for Lovenox, according to Anderson, "might signal what FDA may also ultimately do when it comes to 'true' biologics that generic companies are also pursuing."

In contrast to Lovenox, I think the FDA will likely require at least one clinical trial for the first few FoB’s approved under the FDA’s newly created statutory authority (see #msg-48581353 for details).

The way the FDA handled NVS/MNTA’s Lovenox ANDA does have some prognostic value for how the FDA will handle NVS/MNTA’s Copaxone ANDA, IMO, but I do not think it has prognostic value for how the FDA will handle applications for FoB’s. Regards, Dew

p.s. Tim Anderson is the Bernstein analyst who promulgated the BS in Jan 2010 that MNTA’s Lovenox approval was imminent (#msg-45811783). Given Anderson’s track record, it would not surprise me if Anderson were intentionally writing misleading stuff about FoB’s.