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Re: Vanilla Fitbit post# 33219

Saturday, 01/02/2021 8:37:33 PM

Saturday, January 02, 2021 8:37:33 PM

Post# of 44690
Expanding the original 150 patients to 165 is probably due to covering drop out patients that don't complete the infusions but were enrolled. Maybe even penalty for the early 102 un-blinding. But.
I read the move to 196 as needed to power the new Endpoint targets. It also shows those sites providing patients and their Doctors have seen success. Doctors would not continue to enroll further patients if there were adverse effects.
As they said getting this all done as a small Pharma was a significant achievement.
The Trials are Done and it appears these patients were enough to call this a Phase 2/3 Trial. Both Phase's data seems to be expected thru the 28 day stage for all and 60 day evaluations for many. The data must be significant to run a Phase 3 CT with this few patients and the DSMB approvals.
Strong possibility of an EUA, IMHFO...GLTA...