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Posted On: 02/16/2021 9:42:41 AM
Post# of 153869
"Cytodyn would probably have to do the phase 3 for M/M to be able to give this to everyone."
Certainly possible that they will require a phase 3. If our SC results in an EUA, I would imagine they would start this fairly soon thereafter.
It's also possible that our phase 2 warrants EUA if the SC results are strong, as they support the data seen in the M2M. Don't forget that we did show stat significance in the M2M trial.
Technically the requirement for EUA is " potential benefit out weighs potential risk.". So, it could go either way, but if I'm running the show, and I believe CD12 is a success, I file for M2M phase three trial.
Certainly possible that they will require a phase 3. If our SC results in an EUA, I would imagine they would start this fairly soon thereafter.
It's also possible that our phase 2 warrants EUA if the SC results are strong, as they support the data seen in the M2M. Don't forget that we did show stat significance in the M2M trial.
Technically the requirement for EUA is " potential benefit out weighs potential risk.". So, it could go either way, but if I'm running the show, and I believe CD12 is a success, I file for M2M phase three trial.
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