Saturday, October 03, 2020 5:49:55 PM
"My analysis of the trial strategy suggests that ....
For the P1 With 33 planned to be enrolled and 4 treatment dose rates that could mean 6 or 7 patients treated per dose rate and the balance placebo. This would establish early safety and some initial quantification / indication of short-term viral load decrease.
Based on that, they could potentially shift after 2 weeks to Phase 2/3 with many enrollments. The P2 / P3 might / will likely be at 3 locations ... maybe Philly, Stanford, and Brazil with something like 1,400 enrolled at each location with 600 outpatient, 600 in patient and 200 placebo.
If we are looking at trials progressing rapidly the key metrics will be viral load reduction and safety at 5 days, 10 days, 15 days and around 29 days after treatment. Longer term monitoring can also quantify antibody half life to determine duration of protection.
If SRNE demonstrates 100% reduction in viral load after 5 days then they can quickly shift to P2 / P3 while still monitoring the P1 for longer term effects.
This could progress quite quickly, but will depend on having partnering institutes ready to enroll, having dose supply ready, and getting 5 day results in good order from P1 without any delays or surprises.
Long and strong SRNE!
"The refusal of the real is the number one dogma of our time" Rene Girard
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