Wednesday, May 17, 2023 10:15:45 PM
The FDA or any DSMB isn’t in the business of being impressed by anything. Our sample is just too small to reach statistical significance with the original endpoints of hospitalizations and death even if we would have gotten to 1000 the last 290 or so what have been during the Omicron variant which wouldn’t have helped much, if at all. We haven’t seen the data for the first 210 because at that time the trial was still ongoing but their push to add PCR to the end point as a primary speaks volumes. Add all of the data from Buci’s ugly step sister NAC along with the in vitro studies for Buci show that it should work and work very well. Hindsight is always 20/20 but we would have certainly had the chance to change endpoints and go for an EUA if they would have tracked the symptoms data properly. If we have strong PCR data, symptoms reduction and as a secondary kept folks out of the hospital there will be value here, a lot more than our current market cap which I know isn’t saying much but value none the less!! GLTA
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