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Where we at?, page-278

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    You seem to be intentionally disingenuous given the whole design and purpose of the 002 adaptive study was to first to identify the min most effective dose (in Stage 1) and then have the FDA agree to our recommended dosage for Stage 2 (based on the interim read out of Stage 1 dosings plus additional supportive studies on 2mg/kg x2).

    We have to wait for the FDA teams to review our revised IND submission and then respond before we can restart and NOT beforehand. IMO there very strong basis for them to allow our preferred dosage for Stage 2. In other words almost a certainty once they review the safety profile.


 
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