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seven-up

02/19/15 9:53 AM

#46410 RE: uksausage #46409

I know it is alive have two emails from the FDA stating it is being worked.

I do not think it will reset any clock.

It was the company that asked to correct their comment letter so it could be public. It looks like the FDA granted that request, is all I take from it.

I think the guy in the basement who is working it, was happy to receive something new...LOL

Maybe with a new boss coming in our guy in the basement may move up.
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Simpsonly

02/19/15 10:32 AM

#46416 RE: uksausage #46409

Hi sausage
I don't agree that the publishing of the Regenesis comments re-sets any clocks. FDA has had, and no doubt has been carefully considering, all the comments since May 20th last year. The Regenesis comments are totally supportive of the reclassification efforts of FDA and endorse further simplification of related approval processes. I see the publication of the comments as simple housekeeping, or, in response to a request by Regenesis that it's comments be made public.