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Geo2014

06/07/18 5:37 PM

#3311 RE: scoobey-do #3310

That is new territory for all of us. As far as I know there is no FDA guidance yet.

Geo2014

06/07/18 5:40 PM

#3312 RE: scoobey-do #3310

...also realize we follow ICH/GCP guidelines for clinical trials which are international. I hope it does somehow streamline the process but there are still alot of subject safety issues that need to be ironed out.

Luckysevens

06/07/18 8:32 PM

#3313 RE: scoobey-do #3310

They have to be thru phase 1 to qualify RTT so I expect that was one of the reasons they ended p2 early