Monday, July 10, 2023 5:33:09 PM
re: "presumably 3 in each?"
That's what I presumed, which seemed to me to be too small from which to reach any valuable conclusions, especially in the sick cohorts where it was hoped some efficacy inklings could be gleaned.
Forever the skeptic you know, but I've seen this act before. Design a test that can only be inconclusive, look at the bright side of the scant results, and determine that further testing is justified.....and that more funds will need to be raised.
I'm not sure that this sample will even assure safety.
At least he's giving us stuff to consider.
A few other thoughts:
I have no interest in getting in the middle of this....
"So I guess that is 2 mega-oft-repeated opinions that have been proven wrong so far?"
....but I think some might expect the FDA to be more cautious than the Indian authorities and express opinions based on that thought and the Diwan established failure to have ever sought any FDA protocol approvals.
"So, playing it safe until they show safety, then can include kids, elderly, and sicker subjects."
Ethically that makes sense and you have to start somewhere, but it would require a second Phase 1 test to allow for treatment of those groups and Dingdong says he's gonna fix everybody:
"Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage."
We're gonna need a lotta popcorn for this one, even if "Phase 1a is Progressing Rapidly:" and "Phase 1b to Begin Shortly:".
I can see it now: "Based on the end of the Covid pandemic and the recent increase in Malaria cases both in the US and worldwide we have decided that it is in the Company's interest to pivot away from".....etc.
He's pivoted away from EVERYTHING HE HAS EVER STARTED. A Phase 1 in India is only enough to hold him based on the way he structured the latest deal with himself. I hope you can keep me interested based on the science because based on business practices this is only worth watching for the fumbles.
No matter what it is or who commenced it, I'm against it!
....Groucho
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