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Re: JRIII post# 383740

Thursday, 06/10/2021 1:10:34 PM

Thursday, June 10, 2021 1:10:34 PM

Post# of 688887

"Five minutes before data lock" is a euphemism, dude. Wow, the reading comprehension skills here leave something to be desired.



Dude, don't be so hard on yourself. No one here thinks reading comprehension is your strong suit. But let me help you with yours:

This was a 15-year-long trial. Perhaps you can tell us when "discussions with respective regulatory agencies began",



Well, a good bet would be sometime prior to the release of the FDA Guidance (https://www.fda.gov/media/133660/download) listed on this page under Regulatory Guidance. Probably even before Linda Powers's response, also noted in that section of this page, although the link appears to be dead. So let's say 2.5+ years ago.

or better yet, point me to the PR where they announced the endpoint changes to shareholders.



They didn't, which you (one would hope) know. Although the European/German/UK regulators announced them on their websites as noted in the stickied thread: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158800616 Since those regulators update their websites, as opposed to the process in the US in which companies update the website, it was clearly approved.

Why NWBO decided not to announce it is unknown. However, you haven't provided any explanation as to why not announcing it means anything nefarious.

It might even occur to you, if logical or unbiased thinking were your forte, that the endpoints weren't changed '5 minutes before' the data was unlocked but that the data was unlocked 5 minutes after the endpoints were changed. <---- Hint, there is a subtle difference in these two statements that suggest the reason for delay in unlocking. Just in case you didn't catch it.

At the same time, maybe you can answer the question, why did they change the endpoints? Any ideas? Care to take a stab at that one? Would love to hear your take.



This has been discussed here at length. As noted by you, this was a 15-year trial. During that time, the company and regulators realized that the initial trial design and endpoints were not the ideal means of testing or verifying the efficacy of new treatments and that better alternatives were available. So they . . . gasp . . . added additional endpoints to better show the effects of the treatment.

It always amazes me how people can go on about how NWBO should have released the data 5 years ago 'for the patients' and yet have no problem with a trial design that excludes 1/3 of the patients from initially getting the treatment.

None of this is new. All of this has been discussed at length.

And your ever-present suggestion that the trial 'probably' failed both of its initial end-points remains wholly unsupported by any actual data or analysis and contradicts what we already know about the data based on the blinded result the company has released.
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