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Posted On: 10/09/2020 12:33:55 PM
Post# of 154003
“don't like the idea of six months as a timetable, as posited by another.”
Approval for HIV combo is definitely more than 6 months away and likely longer depending on when the corrected BLA is filed. In the quarterly report that was released today CYDY said that they expect/hope to file the BLA by the end of 2020, but given the need for the receptor occupancy data, it could go longer (or just based on previous timelines taking longer than expected).
In terms of COVID19, if the DSMC halts the trial for efficacy, approval could come much sooner via an EUA and a phase 4. If the DSMC doesn’t stop the trial and the trial has to fully enroll, then it could be another 2-6 months for COVID19 approval, depending on speed of enrollment. The S/C trial was enrolling about 30/month given the most recent update and approximately 150 more patients are needed to fully enroll.
Approval for HIV combo is definitely more than 6 months away and likely longer depending on when the corrected BLA is filed. In the quarterly report that was released today CYDY said that they expect/hope to file the BLA by the end of 2020, but given the need for the receptor occupancy data, it could go longer (or just based on previous timelines taking longer than expected).
In terms of COVID19, if the DSMC halts the trial for efficacy, approval could come much sooner via an EUA and a phase 4. If the DSMC doesn’t stop the trial and the trial has to fully enroll, then it could be another 2-6 months for COVID19 approval, depending on speed of enrollment. The S/C trial was enrolling about 30/month given the most recent update and approximately 150 more patients are needed to fully enroll.
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