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Biotech / Medical : Regeneron Pharmaceuticals
REGN 657.80+1.6%3:59 PM EST

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To: DewDiligence_on_SI who wrote (3275)4/12/2021 2:20:32 PM
From: CuttingEdge Bio  Read Replies (1) of 3557
 
No, this was a study done in an entirely different setting.
I previously argued against the idea that they would/should have to repeat with SubQ their already proven outcomes benefit with IV in the setting of infected high-risk outpatients, which was a massive trial.
This new data with subQ evaluated prevention outcomes in household contacts of people testing positive (or efficacy in those who themselves also tested positive, Trial B). The interim analysis on efficacy for outcomes in household contacts with SubQ formulation was already reported previously. This is the full data with larger n. Neither of these two trials in household contacts who are either PCR positive or PCR negative at baseline, was powered to show benefit on hard outcomes of hospitalization and/or deaths. Presumably they would prevent those hard outcomes, considering it proved to reduce progression to symptomatic Covid in the baseline positives and prevented infections in the baseline negatives.
It is still the case that a much larger trial would have to be run in any outpatient setting to prove reduction in hospitalizations and deaths from a SubQ formulation and this would be entirely pointless to require of them at this point given all the results to date and what they clearly demonstrate.
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