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Re: Bones58gdi post# 6474

Friday, 10/30/2009 12:57:45 PM

Friday, October 30, 2009 12:57:45 PM

Post# of 330428
From comments made by Joe a few months ago, I think he is the one who prepared the Allay filing. So the inept scenario is not out of the question. (Jack of all trades -- Master of none.) You'll note how they are heavily emphasizing their use of consultants on the second set of filings. Reading between the lines tells me the Allay filing may not have been up to FDA standards. The fact that it's been sent back twice now with requests for more info lends support to this.

I still think we'll finally get clearance in about 2 weeks. The application has been beaten to death already.