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Re: raja48185 post# 319567

Sunday, 07/04/2021 11:56:17 PM

Sunday, July 04, 2021 11:56:17 PM

Post# of 462864
Why not expect approval on low dose and when the 2nd trial is completed then add the children and later approve the higher dose after the 3rd trial?

There is an urgent unmet need so why not approve in stages just like the trials were set up? If Excellence and Avatar were not started then what would the FDA do will the low dose trial? It should be obvious.

"We hold FTD, RPDD, and ODD for Rett." Coupled with clinically meaningful & statistically significant data will move the FDA to AA...What's the point in issuing these designations if clinically meaningful and stat sig data isn't enough? Approval in 3 mo

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