Wednesday, January 13, 2021 11:36:40 AM
Thank you for this clarification. It’s VERY helpful.
That’s EXACTLY the point Dr. Zaius was trying to make to someone (can’t remember who) yesterday.
Though I’m fairly confident the trial will show statistical significance, it’s also encouraging to hear that the FDA is only looking for clinical significance for COVID therapeutics. As it should be...
This all just reinforces in my mind that the company made the right decision to continue to trial to the full 28 days for all patients rather than do the 75%/42 day look. If all the FDA is looking for is a well conducted trial with a decent sample size, running CD12 to completion of its original design gives CytoDyn the best chance of handing exactly that over to the FDA. As positive as it seemed like 75%/42 day results would’ve been, running to original completion eliminates any possible objections.
...we were told 45 deaths were on the trial but it was not broken down to how many deaths were within 28 days.
That’s EXACTLY the point Dr. Zaius was trying to make to someone (can’t remember who) yesterday.
Though I’m fairly confident the trial will show statistical significance, it’s also encouraging to hear that the FDA is only looking for clinical significance for COVID therapeutics. As it should be...
This all just reinforces in my mind that the company made the right decision to continue to trial to the full 28 days for all patients rather than do the 75%/42 day look. If all the FDA is looking for is a well conducted trial with a decent sample size, running CD12 to completion of its original design gives CytoDyn the best chance of handing exactly that over to the FDA. As positive as it seemed like 75%/42 day results would’ve been, running to original completion eliminates any possible objections.
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