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SecureInvest

07/14/21 12:11 PM

#389273 RE: exwannabe #389269

I think you are giving NWBO credit for the change of using OS as a criteria for trials. I don't think this PIII trial was the motivating factor for a general change in trial analysis going on for the past year or so in various trials. I am pretty sure those changes came from the scientific community and FDA getting together and deciding that this criteria was far too important not to include in trial result analysis.
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anders2211

07/14/21 1:07 PM

#389283 RE: exwannabe #389269

No, that is wrong.
It means asking the new question based on information from the trial.

lol so it should actually be called post hoc gut feeling you object so much LOL haha Now thats exwannabe science! ;).

NWBO had a ton of trial data for years.


NWBO had zero unlocked data prior to when the revised SAP was submitted to the RA's. Can you provide evidence NWBO was aware of unblinded data when they submitted the revised SAP with the RA's? You still have not provided any evidence for many of your assertions which is also how science work. Evidence.. ex evidence

The "we were blinded" firewall may work in court, not in science.

It has nothing todo with science ex but with FDA rules when and how SAP can be revised. The data is the data. Can you provide me a quote from the FDA + link to prove that NWBO broke FDA rules and why when they submitted the revised SAP? I have asked I think 25x times now still have not seen anything why is that?

I did provide you FDA quotes where its stipulated when a biotech wants to revise its SAP and explained to you that NWBO did not break any of the rules. Im not seeing any source back from you, now why is that?

To make it worse for you what you assert. The WHO did not change the definition of GBM until March 5 2021 way after NWBO submitted the revised SAP







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Dr Bala

07/14/21 1:25 PM

#389293 RE: exwannabe #389269

Totally nonsensical musings.
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biosectinvestor

07/14/21 1:27 PM

#389294 RE: exwannabe #389269

Actually, you’ve got the relevance and who will be driving that conversation backwards.

The FDA will be asking that question. The company has to be prepared answer. That it will likely support DCVax to have that data is irrelevant and ancillary to the FDA’s inquiry following CURRENT scientific thought before they license a drug for a given indication that has now changed in definition. But it is relevant to them as ancillary data that potentially affirms the mechanism anticipated by the science and potentially the evidence of efficacy.
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manibiotech

07/14/21 1:47 PM

#389300 RE: exwannabe #389269

Utter non sense
Being blinded is valid in science and court
Learn before you preach