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Posted On: 12/28/2020 7:27:02 PM
Post# of 153905
nbmbr1:
DSMB works for Cytodyn. They would have recommended changes or halting the trial if they were not seeing results that would reach the expected endpoint.
DSMB protects patients, but also recommends stopping trials that will be fruitless and waste the company's money.
Witness the discussion this afternoon of GVHD raised by CI. The trial was amended in 2018 as the trial structure then would not have produced positive and/or significant results.
Current GVHD stopped either due to slow enrollment in covid environment or lack of efficacy, depending whom you believe.
DSMB works for Cytodyn. They would have recommended changes or halting the trial if they were not seeing results that would reach the expected endpoint.
DSMB protects patients, but also recommends stopping trials that will be fruitless and waste the company's money.
Witness the discussion this afternoon of GVHD raised by CI. The trial was amended in 2018 as the trial structure then would not have produced positive and/or significant results.
Current GVHD stopped either due to slow enrollment in covid environment or lack of efficacy, depending whom you believe.
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