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Replies to #91382 on Biotech Values

DFRAI

03/01/10 11:36 AM

#91384 RE: InTheTrenches #91382

MNTA vs Amphastar
I would expect a quick decision on the approval to put an end to all these accusations going back and forth.

DewDiligence

03/01/10 12:57 PM

#91387 RE: InTheTrenches #91382

(MNTA) From the same article:

(One curious aspect of the purported communication between FDA and the Momenta/Sandoz team is that it mentions only Sandoz, and lists only Sandoz employees as contacts. In press accounts, Sandoz, a division of Swiss pharma giant Novartis, has been portrayed as a silent partner, responsible for financing and the eventual marketing of enoxaparin. Nearly all of the comment on the drug development effort has come from Momenta, which has presented itself as the technology end of the tandem.)

This isn’t curious at all. NVS, rather than MNTA, is the formal applicant for the Lovenox ANDA, and hence FDA protocol dictates that written correspondence about the ANDA be addressed to personnel at NVS.