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vinmantoo

11/08/10 8:30 PM

#108466 RE: HattieTheWitch #108459

<Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation. "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said. >

It depends on why Adams or anyone else felt the process was biased towards MNTA. If it was because MNTA was the only ones capable of definitively showing m-enox was equivalent to Lovenox, then it is obvious why the FDA would and should be "biased" towards them.
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ghmm

11/09/10 6:27 AM

#108499 RE: HattieTheWitch #108459

Although I would have preferred it worded differently obviously I can't be too disappointed in hearing someone within FDA to say our technology is receiving favored status. Bullish for other similar applications we may send through too (I believe we have one of those :-)).