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Re: Rocker424 post# 22478

Monday, 06/11/2012 7:48:51 AM

Monday, June 11, 2012 7:48:51 AM

Post# of 330384
My take on the July meeting for ActiPatch is that FDA folks, who are relatively new to medical devices AND understaffed AND with little funding in the area may have asked if the same rationale as given by the good bio-physicist on ALLAY would be applicable to ActiPatch. Any scientist of merit would have asked for the leeway to re-examine the data and indication and report his findings to the FDA. It also tells me that FDA may have accepted, under advisement, the technical explanation on ALLAY. This all makes sense to me. They all want to get it right on both products. Anyone find any holes in my theory?