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Tuesday, May 14, 2024 1:05:13 PM
I think the endpoint is resolution of symptoms for one day, and we don't know the difference between placebo and treatment yet
Somewhat agree about virology - the differences could be due to pt populations (notably 30% were high risk vs essentially none in SPRINT), but we just don't know yet without the data. This is more supportive anyway - remdesivir for example was approved without showing any virology effects IIRC
Interestingly Shionogi DID see efficacy on the 14 symptom scale in Asia so they are different patient populations when it comes to immunity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858401/#note-ZOI231613-1-s
see table 2 14 symptom scale met stat sig
I don't know if the FDA will be more flexible in light of all these recent failures (add oral remdesivir to the list, paxlovid in standard risk, etc), but usign the 15 symmptom endpoint in a very immune population like we have now is a high bar and I don't know if someone really thinks 235 can clear it - they were 2 days on the 6 most common symptom scale but only a trend I think on the 14 but I don't really recall that data and it was from a smaller study
I think once the actual data are out from scorpio-HR you can try and make some cross trial comparisons
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