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HattieTheWitch

10/15/11 9:17 PM

#128551 RE: jbog #128543

I would think that the FDA doesn't look to kindly to Momenta's IP when trying to protect others from entering the generic field. In many ways I'd say that the FDA will do everything possible to circumvent Momenta.

(my emphasis)

jbog, it's not up to the FDA to "circumvent" Momenta, nor could the FDA circumvent MNTA, IMHO. If Amphastar used MNTA's IP to prove sameness to the FDA, it's not up to the FDA to say "You used MNTA's IP to prove it, so "NO APPROVAL!".

I'm not getting where you're coming from...?