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Alias Born 12/20/2011

Re: silkyslick post# 37540

Wednesday, 01/25/2012 2:11:38 PM

Wednesday, January 25, 2012 2:11:38 PM

Post# of 129054

Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier.
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