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exwannabe

01/01/22 11:37 AM

#431151 RE: dennisdave #431150

Agreed that NWBO would have no reason to wait on that guidance.

Why care about a general guidance when NWBO will get specific comments from the FDA on what they think of their specific endpoints changes? That is far more significant than the general comments on the FDA's present views.

What they are waiting for is just one of those mysteries to be disclosed Monday.

[Everything happens on Monday for some reason]

biosectinvestor

01/01/22 4:59 PM

#431222 RE: dennisdave #431150

I said they hinted they would be done, I did not say it was definitely going to be finalized. It was in a presentation.

And no, your point, even with a link to the FDA website to a page saying specifically nothing in particularly important, to make a nonsense point seem real, is nonsense. You actually have to know what you’re talking about, and that takes more than a superficial point and link.

The trial is an amalgamation of initially bad / dated FDA policy, a long wait for results for survival during which time the laws and FDA policies changed, and then the pending update of policies upon which a revised SAP is based.

That you’d paint such important and critical issues as “nonsense” is wishful thinking perhaps on your part, but most definitely not nonsense. The FDA is still apparently going slow. Not anyone’s fault, just the reality.

The reality is, to express my opinion further only feeds people with the worst intentions. So I choose to stop. But your effort to get me to say more is noted.

And I did not say NWBO is “waiting for it”. They drafted an SAP based on it, likely with assurances it would be policy by the time that the law requires full implementation by the FDA. NWBO is not holding it up at all.