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Re: konshe post# 178171

Thursday, 08/01/2024 3:13:47 PM

Thursday, August 01, 2024 3:13:47 PM

Post# of 178646
You guys are not making any sense… RADIOGEL requested an extension not the FDA. There had to have been something missing or wrong in the ide. This was not solely a time based extension on the FDA’s behalf… if I had to guess it was denied, radiogel requested to return to pre sub to not have to start everything over, and the FDA allowed them to return to pre sub to address deficiencies. There is absolutely no way this was solely a time based 45 day extension… there are things that need to be addressed. All my opinion but I don’t believe the PR’s were specific for a reason… it’s called damage control.
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