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Brinjal

11/04/21 7:57 PM

#381729 RE: sunspotter #381719

The NRx PR announcing the results does not say:

1. It was a double-blind study.
2. It followed the 29-day protocol expected of such studies.

Moreover, the admission process goes something like, and I quote "Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU)". Does this give you sufficient confidence that the admission process was unbiased? Could these be the reasons why FDA was skeptical?

Isn't this a lot different from how IPIX conducted its trial?

Is it time to bring out your "Phosp...", whatever you mentioned before, out of the quiver and regurgitate it?

https://www.nrxpharma.com/nrx-pharmaceuticals-announces-improved-survival-at-one-year-in-highly-comorbid-covid-19-patients-treated-with-zyesami-aviptadil/


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wsbc

11/04/21 8:55 PM

#381737 RE: sunspotter #381719

…to my concern about this being yet another borderline statistically meaningless nano-trial.

I guess we’ll see, but a virologist with whom I spoke had mentioned the size and said ‘it would’ve been much more helpful if it’d been for 300 subjects or so’…

time will tell.

Hopefully bio markers in place will have favorable indications.


“In its letter, the FDA noted that so far, it has reviewed safety in only 131 randomized patients treated with ZYESAMI.”

https://www.prnewswire.com/news-releases/us-food-and-drug-administration-declines-emergency-use-authorization-for-zyesami-aviptadil-for-patients-with-critical-covid-19-with-respiratory-failure-301417228.html?fbclid=IwAR3_cYj8GViBA0asnnbjHH0kFfyXoeb4EyGaOZWqHmTWDmrpS8AWw3Y5Rg8

Note the use of the word “only”.

In IPIX’ study, only around 60 patients with COVID-19 will have received brilacidin.