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Re: skitahoe post# 657571

Wednesday, 12/20/2023 6:45:30 PM

Wednesday, December 20, 2023 6:45:30 PM

Post# of 701421

I forget what class I first heard of the insignificant many, and the vital few. I would suspect that if we looked at the 1.7 million page filing with the regulators, 1.699 million of those pages, or more could be classed as the insignificant many. I really doubt that over 1000 pages in the filing really belong in the vital few, and if you're reviewing what's being submitted, it's these pages that need to be scrutinized.


Have no idea of MHRA.

I have looked over FDA reviews though and they are very in depth. They do not just verify the analysis against the dataset, They will QA they data set against the supporting documents, They will QA check radio scans to see if they agree. They will rerun stats with both teh same assumptions and different assumptions.

And that is just the clinical section. For biologics the CMC section is huge.

Sure, they do not vet every page of the 1M+. Most are just supporting documents that they accept as the factual data. But they will reference that data to verify the core dataset is correct.
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