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hoffmann6383

10/04/22 11:49 AM

#519003 RE: HyGro #518998

LOL, show me anywhere in the prior 886 GBM trials where the trial showed actual 5 year OS data? You can't. Only DCVax-L can show 5 year OS. FYI - OS is the gold standard endpoint. If you had cancer, you would want to be alive at 5 years right?! Well, DCvax-L is the only one of 886 trials that can say yes, you have a better chance of survival if you use DCVax-L.

As far as this post hoc change, that is simply repetitive bullshit. The 5-10 presentation addressed this bullshit and clearly stated no post hoc changes were made.
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biosectinvestor

10/04/22 11:56 AM

#519010 RE: HyGro #518998

There are examples including large pharmaceutical drugs. They are not indexed so calling on people to provide you with examples is pointless. It’s all part of complex back and forth and even searching for it is very challenging but I debated the issue a few years ago where it was maybe Merck, that had approved a special protocol assessment even on their initial SAP, but they gave that up because they needed to revise the SAP based upon the realities they discovered along the way. They were still blinded, as I recall.

And as for post hoc allegations, those are false and FDA regulations explicitly address revising the SAP and what makes such revisions most clearly valid, is submitting prior to unblinding.

You can claim their were “unblinded”, but a Federal Court decision dismissing a claim, on these very matters, says you’re wrong.
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Roman516

10/06/22 7:24 AM

#519651 RE: HyGro #518998

Why, this is what makes NWBO special as you already know and always agree that
NWBO is moving forward in the right direction. Remember it is the patients
that survive as the OS data results not only prove to be effective and the data results work. Thanks for pointing this out and why NWBO is special.
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pgsd

10/06/22 7:38 AM

#519653 RE: HyGro #518998

The phase 3 trial was an 'adaptive' trial and the the statistical analysis plan along with it's endpoints were pre-specified and submitted to regulators before unblinding. So no problem....:-)

https://virtualtrials.org/dcvax/dcvax.pdf

https://virtualtrials.org/dcvax.cfm
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Doc logic

10/07/22 3:03 PM

#520088 RE: HyGro #518998

HyGro,

All part of the exceptions pathway for adequate and well controlled trials which you continually choose to ignore. Feel free to ignore this point but unlike Henny Penny’s influence, I hope that you insisting that an acorn falling (the exceptions pathway) is the sky falling (trial failure) won’t cause a bunch of folks to follow you to something like the fox’s den. Patients deserve the truth even at poker table investment boards. See you and raise your bluff ; ). Best wishes.