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Replies to #84944 on Biotech Values
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DewDiligence

10/12/09 5:39 PM

#84945 RE: wallstarb #84944

MNTA should just offer to pay the FDA the standard NDA fee - grease the wheels a bit! Seems a tad unfair that FoBs can end up in regulatory limbo for a near indefinite period of time.

Generic Lovenox is not an FoB. Perhaps you meant to say that the Lovenox application is an ANDA, which does not have a formal review timeline.

If there were a way to expedite an ANDA review by paying a fee, I’m sure NVS (the official applicant in this case) would have done that.