Sunday, December 11, 2022 4:42:13 PM
HyGro,
First of all, knowingly submitting manipulated data to FDA is a crime that can incur civil or criminal penalties. If what you said were true, which is completely false in my opinion, the reputation of the co-authors and of Jame Dignam responsible for reviewing statistic analysis would be in jeopardy. In Wall Street, the evil doers may come together conspiring something bad like the eight defendants NWBO brought suit against. But I don't think in the medical field, those best neurosurgeons would agree data manipulation at the risk of patient's life.
As for partial hold, everyone knows what caused the partial hold. Partial hold from one perspective reflects the fact that FDA is monitoring clinical trials real time. Does this mean FDA knows the data on the combo trial of DcVax plus poly-iclc and the one mentioned by Linda Liau last week? Is this supposed to be good news?
First of all, knowingly submitting manipulated data to FDA is a crime that can incur civil or criminal penalties. If what you said were true, which is completely false in my opinion, the reputation of the co-authors and of Jame Dignam responsible for reviewing statistic analysis would be in jeopardy. In Wall Street, the evil doers may come together conspiring something bad like the eight defendants NWBO brought suit against. But I don't think in the medical field, those best neurosurgeons would agree data manipulation at the risk of patient's life.
As for partial hold, everyone knows what caused the partial hold. Partial hold from one perspective reflects the fact that FDA is monitoring clinical trials real time. Does this mean FDA knows the data on the combo trial of DcVax plus poly-iclc and the one mentioned by Linda Liau last week? Is this supposed to be good news?
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