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Bourbon_on_my_cornflakes

09/06/18 2:07 PM

#164767 RE: hapit #164765

Rett has been a 2 edged sword.

On the one hand, you should know after 3 months if it works, and the planned trial is big enough that conditional approval will be granted if it works.

On the other hand, because it involves children, and because it is a test case for the new FDA precision medicine approach, there has undoubtedly been an effort by the FDA to double and triple check the trial, and leave no loose ends.

Once we get the go-ahead, we leap forward, but getting the go-ahead taking triple the time expected.

Glad we are moving ahead abroad with PD and alz, and not trying to run them through new FDA anymore.
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plexrec

09/06/18 2:53 PM

#164773 RE: hapit #164765

hapit--"I talked to the IR about it"--thanks for your "intelligent " response !!!!--not all (responses) can be called that !!!
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CkFacts

09/06/18 4:23 PM

#164779 RE: hapit #164765

Thanks for checking hapit !

I still believe that FDA and Anavex both want to have this first “ new regs “ trial done well , hence the time consuming “ back and forth “ .

Additionally , as mentioned almost a year ago ( post 164775 ) , the POSITIVE scientific data
continue to accumulate ( see sokol’s recent excellent summary !} and all true longs are willing to wait !

GLTAL