NP confirms based on FDA feedback one week ago CYD
Post# of 153771
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Posted On: 03/06/2021 9:43:26 PM
NP confirms based on FDA feedback one week ago CYDY submitted new protocol for critical Covid (scale = 2), N=120, could take 4 weeks to enroll (but probably longer), with primary endpoint of time to discharge (easier than mortality). FDA likely to approve trial to start real soon, possibly enrolling within the week.
CYDY in their PR did present some very interesting new data.
Basically, we got very unlucky in that LL arm had 33% over 65, meaning more likely to die, versus only 22% over 65 in placebo arm. So, adjusting for age, our numbers are p=0.055 for mortality.
The other adjustment is that not all subjects received the "standard Covid treatments" (assuming steroids and remdesivir, but as usual, poorly written / unclear), only 309 of 384 did. Of those subjects, we met our primary endpoint (p=0.03)! Unless I misheard something (which is probably the case).
Unfortunately, that was not a prespecified analysis, and FDA won't accept.
FDA only is allowed by law, per NP, to approve for EUA if primary endpoint met (p<0.05). Anyways, NP confirms FDA has spoken. No EUA for CD12. Need more subjects and new endpoint.
CYDY in their PR did present some very interesting new data.
Basically, we got very unlucky in that LL arm had 33% over 65, meaning more likely to die, versus only 22% over 65 in placebo arm. So, adjusting for age, our numbers are p=0.055 for mortality.
The other adjustment is that not all subjects received the "standard Covid treatments" (assuming steroids and remdesivir, but as usual, poorly written / unclear), only 309 of 384 did. Of those subjects, we met our primary endpoint (p=0.03)! Unless I misheard something (which is probably the case).
Unfortunately, that was not a prespecified analysis, and FDA won't accept.
FDA only is allowed by law, per NP, to approve for EUA if primary endpoint met (p<0.05). Anyways, NP confirms FDA has spoken. No EUA for CD12. Need more subjects and new endpoint.
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