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Re: Pineapple1 post# 149708

Wednesday, 05/09/2018 10:13:09 AM

Wednesday, May 09, 2018 10:13:09 AM

Post# of 462979
My Questions:

1. Compared to previous FDA guidance, describe in detail how the new FDA precision science process rules have impacted/influenced the A2-73 trials structure, metrics and planning process milestones for RS, AD, PD.? (eg. Timelines, metrics, including measurement devices/tools, RWE guidelines, pass/fail criteria).

2. How and How much will AI be used in planning, conducting and measuring trials results?

3. What specifically will you evaluate to validate that the claim of CNS Homeostasis restoration has been achieved with A2-73?

4. Do you have specific CNS cellular restoration or regeneration targets?
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