“There is only ONE criteria that should determin
Post# of 148187
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Posted On: 10/10/2020 4:09:39 PM
Re: Cassandra X #60690
“There is only ONE criteria that should determine the DSMB's decision to allow an EUA for Leronlimab in my opinion - IS IT SAFE!”
The DSMB does not grant EUA, the FDA does. The DSMB can recommend halting the trial due to EFFICACY but that data will still have to be submitted to the FDA for EUA/approval. The DSMB will not recommend to continue or stop the trial because leronlimab is only safe without data showing its efficacy.
“In these extraordinary, EMERGENCY times, with the suffering incurred by the virus and a limping economy, efficacy should not be the first priority for approval.“
You lost me. Efficacy is paramount for any drug that is being tested in trials for an indication. The FDA is not going to grant EUA for a drug to treat COVID just because the drug is safe.
The DSMB does not grant EUA, the FDA does. The DSMB can recommend halting the trial due to EFFICACY but that data will still have to be submitted to the FDA for EUA/approval. The DSMB will not recommend to continue or stop the trial because leronlimab is only safe without data showing its efficacy.
“In these extraordinary, EMERGENCY times, with the suffering incurred by the virus and a limping economy, efficacy should not be the first priority for approval.“
You lost me. Efficacy is paramount for any drug that is being tested in trials for an indication. The FDA is not going to grant EUA for a drug to treat COVID just because the drug is safe.
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