Ohm - I've been trying to understand the basis for
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Posted On: 10/29/2020 12:16:49 AM
Ohm - I've been trying to understand the basis for reporting the Regeneron data out as well, and whether that has bearing on CYDY. I appreciate the board tolerating a bit of off topic geek-out.
Best I can tell this is an end-of-phase-2 readout of the 2,104 person, P 1-2-3 "master protocol" NCT04425629. They say the "seamless" P-3 section is ongoing. In P-2 viral is primary, clinical secondary. That reverses in P-3.
So no undue "unblinding," but no claim clinical was primary.
The initial 275 (P-1?) patients delivered descriptive data only regarding virus loads; the next 524 (P-2?) confirmed better viral load reduction than placebo. These #s were way significant - the drug cloaks the virus spike all right.
Then both groups were combined on the clinical outcome, which is called in the PR "COVID-19 related medical visits" while the trial says "% patients with at least 1 medically attended visit" - potentially very different. The number is quoted as "6.5%" vs. "2.8%," supporting the latter interpretation.
That means only 37 of every 1,000 dosings prevents a person from seeing a doctor. Using Regeneron across the whole group (that's the p=.024), a reasonable WAG is that it's likely to require 500-1,000 dosings per life saved.
The subgroup with one or more risk factors had a greater % improvement over placebo, at higher significance (p=.0065) - def worth an EUA bid. That said, adding WAG to WAG, it's hard to imagine that group yielding better than 1 life saved per 100 dosings.
My read: great news for individuals but barely a dent socially. How many doses are available? The "trial of the sickest" (CD-12) will show leronlimab saves the most lives per dose.
Best I can tell this is an end-of-phase-2 readout of the 2,104 person, P 1-2-3 "master protocol" NCT04425629. They say the "seamless" P-3 section is ongoing. In P-2 viral is primary, clinical secondary. That reverses in P-3.
So no undue "unblinding," but no claim clinical was primary.
The initial 275 (P-1?) patients delivered descriptive data only regarding virus loads; the next 524 (P-2?) confirmed better viral load reduction than placebo. These #s were way significant - the drug cloaks the virus spike all right.
Then both groups were combined on the clinical outcome, which is called in the PR "COVID-19 related medical visits" while the trial says "% patients with at least 1 medically attended visit" - potentially very different. The number is quoted as "6.5%" vs. "2.8%," supporting the latter interpretation.
That means only 37 of every 1,000 dosings prevents a person from seeing a doctor. Using Regeneron across the whole group (that's the p=.024), a reasonable WAG is that it's likely to require 500-1,000 dosings per life saved.
The subgroup with one or more risk factors had a greater % improvement over placebo, at higher significance (p=.0065) - def worth an EUA bid. That said, adding WAG to WAG, it's hard to imagine that group yielding better than 1 life saved per 100 dosings.
My read: great news for individuals but barely a dent socially. How many doses are available? The "trial of the sickest" (CD-12) will show leronlimab saves the most lives per dose.
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