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Impailer

12/22/20 9:22 AM

#135206 RE: Blue Man #135202

True but at least the primary outcome is only 28 days.
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SF Anony

12/22/20 9:30 AM

#135213 RE: Blue Man #135202

Estimated completion date is March 23, 2021. Not sure where badge04 saw 91 weeks?

I could be wrong, but I don’t think they have to recruit a patient and wait for them to BECOME a long hauler. I think they’re looking to accept patients who are ALREADY long haulers and show that their symptoms can be cured relatively quickly. Primary end point is change in Fatigue Severity Score at 28 days.

Total patient number is 102. With the number of long haulers identified (possibly even people who CytoDyn has already talked to because they were candidates for or enrolled in the Mild/Moderate trial) I think the trial will fill rather quickly.

My guess: They’re shooting to fill the trial by the end of January, complete the 28 days for the last patient by the end of February, and have the results by the end of March.

Maybe a twofer with HIV BLA and Long-Hauler approval around the same time?
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Badge04

12/22/20 9:41 AM

#135217 RE: Blue Man #135202

Absolutely. The duration is completely necessary but it sure slows down moving to/through phase 3. Lots of people impacted along the way..