Friday, September 09, 2022 9:30:23 AM
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.
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.
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