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cybermich

08/08/20 2:37 AM

#317863 RE: DaubersUP #317862

I get your point..
"Small and quick trial is my guess."

My thinking as well (I included something like that in my post.).. but if the FDA is truly looking at expediting with the right data this could bode well for the process to surprisingly move quickly once the trial is started..

at the very least the RV*TF situation gives an example where the FDA is willing to move quickly with the right information.

This also underlines how critical it is for us to get all the RBL testing done and to get their full recommendations with data and peer reviews..

this just might give the FDA enough information to move quickly (either before or after phase 2 commences.)

Daubers.. I actually like you making the statement "there is a major difference from a drug dosing 400 plus in clinical trials and a drug approved for the past 30 years" because it brings some sanity to the process and might explain why we aren't just skipping multiple steps based on partial data..

I believe we are just where we want to be.. and it won't take much more for us to move very quickly through the process:)