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Posted On: 02/16/2022 10:22:02 AM
Post# of 148899
cytodyn was supposed to release 700 mg nash results in dec 2021.indeed bp received these nash results but not we the shareholders.something definitely up
with that!
Chris Recknor, M.D., Senior Executive Vice President of Clinical Operations, commented, “We are encouraged by the preliminary results from the open label portion of our NASH trial. The CT1 reduction from baseline for these patients is approximately 40 msec, which would be consistent with an observed reduction in fibrosis on biopsy. We expect data lock in December with results from the 700 mg double blind placebo-controlled part 1 and the remaining part 2 open label with 350 mg. We are working on a new Phase 2b/3 protocol to include biopsy to start in January 2022 with our new CRO, Cato Research LLC (CATO SMS), which has extensive experience with NASH trials.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe these early findings represent a very significant therapeutic opportunity for patients suffering from this disease, encouraging us to aggressively pursue a NASH indication with potential for Breakthrough Therapy designation (BTD). Our team is currently preparing the BTD application for 350 mg arm, which could include 10 patients’ data by mid-November. We are also very optimistic for our 700 mg arm, which was double blinded; and we hope to unblind the data and announce those results in early December.”
with that!
Chris Recknor, M.D., Senior Executive Vice President of Clinical Operations, commented, “We are encouraged by the preliminary results from the open label portion of our NASH trial. The CT1 reduction from baseline for these patients is approximately 40 msec, which would be consistent with an observed reduction in fibrosis on biopsy. We expect data lock in December with results from the 700 mg double blind placebo-controlled part 1 and the remaining part 2 open label with 350 mg. We are working on a new Phase 2b/3 protocol to include biopsy to start in January 2022 with our new CRO, Cato Research LLC (CATO SMS), which has extensive experience with NASH trials.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe these early findings represent a very significant therapeutic opportunity for patients suffering from this disease, encouraging us to aggressively pursue a NASH indication with potential for Breakthrough Therapy designation (BTD). Our team is currently preparing the BTD application for 350 mg arm, which could include 10 patients’ data by mid-November. We are also very optimistic for our 700 mg arm, which was double blinded; and we hope to unblind the data and announce those results in early December.”
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