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biosectinvestor

07/18/21 11:56 AM

#390118 RE: trocprofit #390116

I agree it is likely soon. Difficult to know if they’ve applied for an extension.

Whether they do or not, I don’t think we would be in the loop on an extension request, and certainly not likely initially to know of it.

But I agree that I think the pending release date nears every day and gets more and more likely to happen any day now.
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exwannabe

07/18/21 12:36 PM

#390120 RE: trocprofit #390116

Official Trial Completion Date: (per August 19th, 2020 PR) Probably happened a few days prior to PR.


All we know of the actual primary completion date is that it was after Dec '16 and before mid July '20 (the PR that said all information from the sites was in hand).

The date is not the date when they have all the data. It is the date of the last patient evaluation in the data used for the primary analysis.

It is far from clear the 12 month rule applies. If the primary completion date was prior to Jan 18, 2017 it does not. If NWBO will be planning to file a BLA it dose not apply.

And the same law (42 CFR Part 11) also required NWBO to update the actual patient counts, completion dates and endpoints long ago. So not like LP cares about violating those laws. She is a lawyer and knows very well how to play the game.
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vator

07/18/21 3:04 PM

#390146 RE: trocprofit #390116

Beyond August I will consider Harakiri. Better yet the management team should give it a go and save face.