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Re: otclife post# 53560

Wednesday, 04/19/2017 9:03:49 AM

Wednesday, April 19, 2017 9:03:49 AM

Post# of 106844
You gotta remember that RMAT is new and anytime the government rolls out a new protocol or procedure there will be growing pains. There is nothing in writing, anywhere online, relating directly to RMAT timeline procedures after additional information requests. That's a fact.

There is plenty of information regarding other approval processes timeline, but not RMAT. I challenge someone to please prove me wrong here.

Just gotta have faith here. It's a new FDA program and they are being cautious. The good news is that the new director of the FDA wants faster approval processes for new treatments like the ones that usrm are proposing.