Orphan drug is not up to him. It is FDA. I believe that with this update he want to know when the last patient for P3 adjunct study will be , or was injected, only after that he can say when study will be done. So , imo as soon as they will have a last patient injected, ( from the 300 ) , update will come.
This is an update after talking to CRO - completely internal matter to CYDY and not dependent on fda and/or BTD.
As per clinicaltrials.gov site - there are 25 sites active and recruiting - out of which 7 have stopped enrollment but are active. Does it mean these 7 sites got allocated patients or they are unable to find.
Based on these site activity - the CRO can easily give conservative estimate on enrollment timeline. This may not need 4-6 weeks.
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