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Re: dadofmarcmax post# 114281

Monday, 08/07/2017 1:09:29 PM

Monday, August 07, 2017 1:09:29 PM

Post# of 462358
The PR said "...The respective trial designs are based on broad genomic and biomarker characterization, pharmacokinetic and pharmacody..."

So assuming that they have pk/pd data and they have designed trial we still have few questions

- have they even contacted fda for consultation? Maybe yes - maybe not yet

- have they submitted IND for Rett yet? This allows fda to review the trial protocol and approve the trial design - it takes 60 days from IND submission.

The preparation of trial including design of protocol to submission of IND. so I expect company to issue PR for IND submission for each indication.

In that sense fda approval of trial will not be a sudden surprise and I expect to hear progress in this area beforehand.

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