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.