Hi meagain
In my opinion POH have no approval whats so ever to do any trials phase2 or Phase 3,
They are yet to even submit an IND.
They have advice that they might be able to go straight to phase 3 via a 505(B)(a) ruling.
I dont believe at this stage they have been notified that thats the case.
If so it should read We have been notified by the FDA, like every other Biotech announcement.
Regards,
esra oxypatch 4 years., page-49
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