Dr J "What we saw in CD10, remarkably, was a very
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Quote:
Dr J "What we saw in CD10, remarkably, was a very clinically significant reduction in SAE....I've been the principal investigator on 300 studies and I've never seen a study where the active drug arm reduced the SAE compared to placebo- we never see that, and that really is for patients with COVID, the important metric period."
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I think this point deserves to be drilled into deeper. With almost all drugs, SAE increase in the treatment arm due to side effects of the drug. We know Leronlimab is safe, so we tend to gloss over this and move on to the primary endpoint.
Setting aside the primary endpoint for a moment, what does the SAE reduction mean? It means that there was a substantial reduction (64%) in negative outcomes for the patients within the 14 day timeframe. Less progression, less intubation, less oxygen, etc.
But but but, "thats not one of the endpoints!" I know but it is THE POINT
What the secondary endpoints will show is how fast the patients improved, as well as the trendlines of the metrics, meaning it will shed light on what is likely to occur AFTER 14 days. This will show (IMO) that all patients were improving on Leronlimab, and presumably some are not on placebo.
Regardless of whether we receive EUA, this data (IMO) will prove that Leronlimab works on COVID, and will definitively show that Leronlimab works on all patients .
While I cannot speak to what the powers that be will do with this information, I believe that validation of the MOA, will be the beginning of some great things for Leronlimab and the treatment of COVID.