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Steady_T

07/08/19 2:32 PM

#200089 RE: Doc328 #200086

Thanks for that analysis.
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Kmadd

07/08/19 3:02 PM

#200094 RE: Doc328 #200086

N=30 for Avatar study so 45 total. Plus the 7 weeks turns into an ongoing 12 week study if the patient decides to keep going.
Should be able to get plenty of statistically relevant data from that group.
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dadofmarcmax

07/08/19 3:16 PM

#200097 RE: Doc328 #200086

a 12 week trial for Rett - would be sufficient enough if you were to check for a 50% responder rate for improvement of seizures.

Look at the most recent phase 3 trials for Briviact, Vimpat, Aptiom, etc - all were a 12 week period before open phase study began.

If the Rett trial is to show clinically significant reduction of seizures from baseline - 12 weeks is sufficient, in my opinion.