I think the odds are low that the announcement ton
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Posted On: 08/23/2020 3:00:38 PM
I think the odds are low that the announcement tonight concerns Leronlimab> Multiple news sources and people like Gottlieb are saying its plasma.
However, this is the first time I think it's possible for these reasons:
1) The biggest risk for the FDA is to approve something that hurts more than it helps. I think with the CD10 safety, CD12 safety review, EIND results, and HIV data makes it defensible to say the drug will do no harm when given to 1000s of people. UK acceptance in CD12 shows it passed UK safety.
2) Showed efficacy for moderate patients in CD10 for NEWS2 and SAEs. Not really any other drugs that can say that in a trial.
3) Request EUA not long ago, and deserves a response.
4) The FDA may have data from the CD12 safety look suggesting no negative surprise when that trial is completed. They would not want to approve based on CD10 and have a poor result a couple months later on CD12.
5) Dr. P saying on tape (not a rumor) that they have been contacted by OWS.
6) Unusual activity in the stock on Friday
7) Stock boards have quit talking about how the stock it going to $100. In my experience that is a bad sign for a stock.
However, this is the first time I think it's possible for these reasons:
1) The biggest risk for the FDA is to approve something that hurts more than it helps. I think with the CD10 safety, CD12 safety review, EIND results, and HIV data makes it defensible to say the drug will do no harm when given to 1000s of people. UK acceptance in CD12 shows it passed UK safety.
2) Showed efficacy for moderate patients in CD10 for NEWS2 and SAEs. Not really any other drugs that can say that in a trial.
3) Request EUA not long ago, and deserves a response.
4) The FDA may have data from the CD12 safety look suggesting no negative surprise when that trial is completed. They would not want to approve based on CD10 and have a poor result a couple months later on CD12.
5) Dr. P saying on tape (not a rumor) that they have been contacted by OWS.
6) Unusual activity in the stock on Friday
7) Stock boards have quit talking about how the stock it going to $100. In my experience that is a bad sign for a stock.
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