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DewDiligence

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Re: oldberkeley post# 12911

Friday, 02/25/2011 1:10:38 PM

Friday, February 25, 2011 1:10:38 PM

Post# of 24569

It comes down to data gathered after the NDA submission. Is there an actual protocol for submitting this type of data? Give them a call and say, "Hey, we have some more data, we're sending it over?"

Yes, it’s common for applicants to submit additional data during an FDA review, but this can cause the PDUFA date to be extended.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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