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Posted On: 04/28/2022 5:21:52 PM
Post# of 148884
Sean:
It's four weeks to the day since the conference call and one of the first topics mentioned was that the FDA was requiring aggregated safety data across ALL indications and the time line for completing this issue was given as eight to twelve weeks. Dr. Kelly quoted as saying it's "a solvable problem and they will correct this" - So patience is needed while they tackle the assignment.
Regarding NASH, their was a Jan. 5th press release claiming the 14 week clinical trial " achieved primary endpoint in both intention to treat & per protocol populations" & they were " in process of analyzing biomarker data to better understand responder rates & MOA" -
During the CC Dr. Recknor did state they were "conducting final analysis with new CRO and planned to release the the results in near future - he was very "excited about results" and optimistic toppling would be available shortly"
It's four weeks to the day since the conference call and one of the first topics mentioned was that the FDA was requiring aggregated safety data across ALL indications and the time line for completing this issue was given as eight to twelve weeks. Dr. Kelly quoted as saying it's "a solvable problem and they will correct this" - So patience is needed while they tackle the assignment.
Regarding NASH, their was a Jan. 5th press release claiming the 14 week clinical trial " achieved primary endpoint in both intention to treat & per protocol populations" & they were " in process of analyzing biomarker data to better understand responder rates & MOA" -
During the CC Dr. Recknor did state they were "conducting final analysis with new CRO and planned to release the the results in near future - he was very "excited about results" and optimistic toppling would be available shortly"
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