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Steady_T

07/04/21 11:55 PM

#319577 RE: Bourbon_on_my_cornflakes #319571

Maybe not. You are assuming that more is better. Given that 5 MG dose had such an impact on the adult subjects, it is entirely possible that 30 mg or 50 mg may cause too much of change in an already disturbed system.

I hope that is not the case and suspect that it probably isn't, but there is no way to know until it is tried. Waiting for the trial results of the adults in the higher doses is a wise thing to do.

It is also entirely possible that the beneficial effects plateau at a much lower dose in Rett than in AD so maybe 5mg or 10 mg is the maximum effective dose in Rett patients. Again, the only way to know it to run the trials.

If the FDA was to approve 2-73 based on the present evidence, the dose would have to be 5 mg and only in adults. Wait a little longer and the results might turn out to be much better with higher doses. Wait a little more than that and the FDA may be able to authorize 2-73 for pediatric as well as adults at doses that are know to be safe and effective.

The FDA and the people giving the drug to their children want and need to have confidence that 2-73 will be safe and effective. The ongoing trials will hopefully provide that to them.

attilathehunt

07/04/21 11:58 PM

#319579 RE: Bourbon_on_my_cornflakes #319571

Absolutely! The FDA should should approve the use of low dose now. They can add in the two groups were the are completed and analyzed. That’s why I say in 3 months.