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Posted On: 04/26/2018 2:02:10 PM
Post# of 15624
Speculation on my part, could it be that the reason that no trials since our initial filing of the Phase 1 for the cream have been put into the clinical trials database is because of the Red Tape the company found they had to deal with in working with our FDA.
I speculated about this on the other site, and I certainly don't know. Does anyone know if our FDA must completely agree to the protocol of a trial before it can be put into the database, even if the trial is not being run in the U.S.
It's my belief that Phase 1 and 2's can be run elsewhere, and if data supports it, a Phase 3 can be run in part in the U.S. that can result in approval here.
Gary
I speculated about this on the other site, and I certainly don't know. Does anyone know if our FDA must completely agree to the protocol of a trial before it can be put into the database, even if the trial is not being run in the U.S.
It's my belief that Phase 1 and 2's can be run elsewhere, and if data supports it, a Phase 3 can be run in part in the U.S. that can result in approval here.
Gary
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