I hope that is not necessary. Surely they prove safety and efficacy with this trial, although I guess the ultimate goal would be to present data to US FDA, especially after phase 2. Maybe a second phase 2 would be required to get all required data formatted for that? I guess even if that is worst case at least we can go forward now knowing it is safe and effective, just a case of formatting data for more major milestones
Ann: Positive Safety Data from Phase 1 Clinical Trial, page-107
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