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Re: Giovanni post# 31759

Monday, 05/16/2022 3:32:44 PM

Monday, May 16, 2022 3:32:44 PM

Post# of 36602
This turn of events is exactly what happened to RLFTF. They had to seek permission from the FDA to change their primary end points because the efficacy was not meaningful. Once the endpoints were changed, then they had the efficacy. This whole process added MANY months to the whole process. They had other issues though that went beyond the need to change end points. They are now awaiting for the NHI trial results year YEND. The FDA process can be a longgggg and painful process!!