News Focus
News Focus
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hoffmann6383

09/09/22 12:05 AM

#512205 RE: HyGro #512202

Yes, Dr. Liau thinks NVCR data is confounded (not nwbo):

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Dr Bala

09/09/22 12:09 AM

#512209 RE: HyGro #512202

Totally nonsensical fabrications.
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meirluc

09/09/22 12:36 AM

#512232 RE: HyGro #512202

Placebo is safe too, the issue is does the trial show valid efficacy results or not.


Are you saying that the overall survival results which have demonstrated the remarkable efficacy of DCVax-L are less reliable in establishing that efficacy than the confounded PFS results that have been plaguing this trial?
Your posts seem to indicate that OS is a surrogate for PFS rather than the other way around.
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Roman516

09/09/22 6:12 AM

#512246 RE: HyGro #512202

Same old store new day
We already know about PFS measurements objectives that Dr. Linda Liau stated in 2018, the OS results prove that DCVax=L works and supersedes the PFS, so move on.
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Doc logic

09/09/22 9:30 AM

#512289 RE: HyGro #512202

HyGro,

FDA stops trials for safety issues, ethical issues AND success ie enrollment to the point “statistically necessary” as stated by Fraunhofer. A company is not compelled to stop the trial, though, when intervened with for positive reasons like determined success if they are not ready to move ahead with a cogent plant to meet expected demand and or want to make a better case for reimbursement purposes with stronger data to ensure business success. FDA will only intervene to disclose negative reasons if the company does not do so timely. I would say that the data shared speaks for itself as to why the enrollment halt occurred and FDA has had 7 years to report bad news and the reason why they let the treatment arm fully enroll into a “failed trial” after the screening halt.
You see HyGro, none of us believe the regulators are as foolish as you make them out to be by your opinions. Your interpretation of this is the only confounding going on that hasn’t been accounted for and you have already disclosed your position in NVCR which is and was being hammered by the expected and reported success of DCVax-L. Your bias towards NVCR is rational just not logical given your situation and the facts. Best wishes.