Not sure where to post, but this thread looks good...
I prefer to stay neutral politically, and to see politics stay out of medical practice and scientific development. But I will point out that IMO the so-called "deep state" (ie The Swamp that I talked about a while back) dropped the ball on convalescent plasma. They should have organized with the FDA to HCT/P-exempt it (like blood transfusions). It meets the minimal manipulation and homologous use criteria for an exemption - I think it's 2 patients treated per donor or something in that range - and patient's are ABO matched before infusion - just like with a blood transfusion. That would be no big deal. Instead convalescent plasma, used for over 100 years in medical practice, is getting an "Emergency" Use Authorization. The public has no idea what that is, but it sounds impressive and urgent and scores points for the President. Meanwhile, some 70,000 Americans have already received it... with at best "mixed" results. Best given ASAP after the diagnosis, it's not a product for ventilator cases. Rem-L will get its failures. I doubt any sponsor has plans to go for a BLA. So, it will sit with an EUA indefinitely until the pandemic fades out and convalescent plasma fades with it. Democrats dropped the ball, congratulations Mr. President. Meanwhile the published study had High, Medium and Low anti-SARS titers. Each batch is a little - or a lot - different. And they talk about FDA standards for a "homogenous" product. Give me a break! Should not be under FDA purview other than to inspect collection sites for proper technique. In any event, it's not a threat to rem-L use in the ICU. Not a competitor. IMO
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