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DewDiligence

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DewDiligence

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Re: None

Tuesday, 05/16/2006 10:09:12 AM

Tuesday, May 16, 2006 10:09:12 AM

Post# of 257484
Indiplon moral?

KISS! Keep NDA/BLA submissions manageable. Don’t submit three zillion clinical studies and analyses. Limit the material to what the FDA can realistically review during the PDUFA review period. More info can be submitted later as part of an sNDA/sBLA.

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

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