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Alias Born 07/31/2017

Re: noreen post# 3318

Friday, 08/04/2017 10:01:23 PM

Friday, August 04, 2017 10:01:23 PM

Post# of 18220
The question to ask(demand) from the company is: Are the Phase 2 studies indicated for LDN in the Power Point presentation actual FDA reviewed and approved studies that were commenced after the appropriate meetings with the FDA and performed under FDA Good Clinical Practices (GCP) as would be required. These would be the ONLY Phase 2 studies that could be used to eventually obtain FDA approval to move to Phase 3 studies and eventual FDA approval to market for the specific clinical indications.