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Re: lumpy9200 post# 2511

Friday, 07/03/2020 10:07:28 AM

Friday, July 03, 2020 10:07:28 AM

Post# of 2676
Drugs do get approval from FDA that don’t meet statistically significant results on there primary endpoints, but they must have something else to ride on for there approval. Zygel has this. To comment on why they did not go back to FDA in the middle of trial and ask to change endpoints.... your not allowed. But I suspect that the company did recognize the way there earlier trials were going and that’s why they had the ADHOC trial splicing out the High Methylated Group. They knew this and prepared. They likely even already know what the FDA will say and this was the best pathway to be able to prove there drug works to FDA. IMO this drug is going to market. For FX, ASD, & Epilepsy. IMO this will be a block buster billion dollar drug.