Wednesday, March 23, 2022 12:55:30 AM
It wasn't a random selection -- it didn't have a matched panel, it wasn't a quota sample that would be required to be a viable subsample. It was a post-hoc, data dredged sample.
The critical patient sample was not statistically significant -- NP used inappropriate statistical methods to claim it was. The FDA Statement reprimanded him for misrepresenting and manipulating the CoV data.
Trials for an indication are ONLY useable for that indication and aren't used for other indications other than possibly for safety to help start Phase 2 for other indications.
Brazil trial is dragging significantly and the company is running out of money and may not be able to complete. The U.S. trial is not likely to happen, again no cash to finance. It is looking less likely that the company will be able to complete a trial that will meet U.S. FDA requirements.
The critical patient sample was not statistically significant -- NP used inappropriate statistical methods to claim it was. The FDA Statement reprimanded him for misrepresenting and manipulating the CoV data.
Trials for an indication are ONLY useable for that indication and aren't used for other indications other than possibly for safety to help start Phase 2 for other indications.
Brazil trial is dragging significantly and the company is running out of money and may not be able to complete. The U.S. trial is not likely to happen, again no cash to finance. It is looking less likely that the company will be able to complete a trial that will meet U.S. FDA requirements.
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