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Re: Vanilla Fitbit post# 38471

Saturday, 04/17/2021 3:28:01 PM

Saturday, April 17, 2021 3:28:01 PM

Post# of 44690
NRX/Dr JJ seem to have messed up the IV CT timelines thru early interim data(un-blinding) and then did not have sufficient power to pass the FDA EUA. This then required to increase the total enrollments to 196, also delaying everything. Data for the CT Trial is still not fully transferred to Relief. That seems a good argument for Relief not paying for those costs, IMO.
The data publicly released so far, 'meets all endpoints' and ALL data from the EAP patients (which NRX was Not running) is Relief's, IMO.
The new Swiss efforts and Turkey CT will move Fast, IMO. EMA asap, IMO...GLTA...