They should have now 45+29+ Combo patients. NP
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Posted On: 02/01/2019 6:36:11 AM
They should have now 45+29+ Combo patients.
NP said around 30 combo patients still in extension study, so that gives around 104 at 700mg now. But they will need to be on it 24 weeks for safety data. The FDA talk was in December, I assume before the shutdown, so early December. So end of May would be my guess as to when the have the safety data for the 100 to submit BLA. Tight line to keep 100+ though assuming few drop out. My guess is to why they are enrolling a few more mono patients at 700mg.
CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.
NP said around 30 combo patients still in extension study, so that gives around 104 at 700mg now. But they will need to be on it 24 weeks for safety data. The FDA talk was in December, I assume before the shutdown, so early December. So end of May would be my guess as to when the have the safety data for the 100 to submit BLA. Tight line to keep 100+ though assuming few drop out. My guess is to why they are enrolling a few more mono patients at 700mg.
CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.
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