Saturday, September 02, 2023 7:58:40 PM
exwannabe,
NWBO checked on other measures to properly account for pseudoprogression including IRANO. None worked well enough to adequately measure PFS. You have done enough due diligence to know this. You may not wish to discuss what you know to be true but JAMA Oncology knows this as well as the regulators. Their opinions are the ones that count and by the way, the regulators were the ones that kept out 17 SOC/placebo patients but allowed all treatment arm patients to fully enroll thus decreasing the powering of this trial. The explanation for this came from Fraunhofer in their annual report stating that enrollment occurred to the point statistically necessary. The findings shared at NYAS and JAMA Oncology in 2022 confirm this much to your chagrin. That action virtually guaranteed an approval after NWBO came up with a way to mass produce their personalized vaccine and move past the roadblocks like product release and supply chain issues so that it could eventually be used in all solid tumor cancers. Being forced into this longer path paved the way for Direct which is a much more substantial threat to big pharma. Linda used the time to make lemonade; ). Best wishes.
NWBO checked on other measures to properly account for pseudoprogression including IRANO. None worked well enough to adequately measure PFS. You have done enough due diligence to know this. You may not wish to discuss what you know to be true but JAMA Oncology knows this as well as the regulators. Their opinions are the ones that count and by the way, the regulators were the ones that kept out 17 SOC/placebo patients but allowed all treatment arm patients to fully enroll thus decreasing the powering of this trial. The explanation for this came from Fraunhofer in their annual report stating that enrollment occurred to the point statistically necessary. The findings shared at NYAS and JAMA Oncology in 2022 confirm this much to your chagrin. That action virtually guaranteed an approval after NWBO came up with a way to mass produce their personalized vaccine and move past the roadblocks like product release and supply chain issues so that it could eventually be used in all solid tumor cancers. Being forced into this longer path paved the way for Direct which is a much more substantial threat to big pharma. Linda used the time to make lemonade; ). Best wishes.
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