Jd Bell@JdBell20
Joined February 2021
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#AmericanAirlines flight 2610 Austin to Dallas. I can't stress this enough, the worst flight I've been on in the 3 mill miles I've flown on American, nothing but delays. Delays that could have been avoided. Keep up the great work. Terrible communication from flight crew.
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$NWBO can someone explain to dumb Tony V sense he blocked me any doesn't want you to know the truth...You Can't File a BLA Without an Active, Inspected Commercial Facility: In December 2023, Sawston was the only facility fully built out, licensed, and validated for commercial GMP
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$NWBO You don't hire an experienced US regulatory affairs and dendritic-cell manufacturing veteran from Roswell Park (Joanna Stanson) just to celebrate a UK MHRA approval—Sawston and Advent already have their own UK Qualified Persons (QPs) and regulatory staff handling the MHRA.
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$NWBO You hire US QA/RA leadership to handle CBER/FDA Type C and Pre-BLA interactions! I'm not going into all the avenues NWBO could use. Because you can be dumb and still know they will have rolling bla and/or RTOR.
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Then the mother of all waves comes! Its happening! The play book has been provided! Read up FUDs! The have war game this out!
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$NWBO NWBO already holds an active Investigational New Drug (IND) file with the FDA (under which the Phase 3 trial was conducted in the US), they already have an open, encrypted communication channel via the FDA Electronic Submission Gateway (ESG) with the Office of Therapeutic
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$NWBO real question? Has anyone lost a family member or a good friend to cancer? Serious question. Anyone see the last few days of what cancer looks like? It's not pretty! But here's a chance to push cancer further out! Why not? Is it that difficult to want to win?
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$NWBO I need to explain something. If NWBO had locked down the trial, banned crossover, and let those control patients die without ever getting the vaccine, the trial would have been a pristine, textbook Randomized Controlled Trial. the drug would have been approved yrs ago.
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$NWBO I want people to think about this. Neither the Flaskworks manufacturing system nor the dendritic cells themselves know the tumor came from a human brain. Biologically and mechanically, the entire DCVax platform is 100% tissue-agnostic.
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$NWBO that's not their job. They don't go hey that tumor is in the lung, did you not get the message we are only indicated for gbm. the only reason DCVax-L is classified as a "glioblastoma treatment" is because humans built a legal framework that requires it.
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$NWBO At the microscopic level, nature doesn't have an oncology department. A dendritic cell doesn't know what a brain is, and a T cell has no concept of a medical specialty. The immune system asks only one simple, elegant question: "Are you self, or are you non-self?"
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$NWBO it really does make you think? Are we humans this dumb? As smart as we think we are as a human species we are not even close. We trap ourselves because the very cognitive tool that made humans smart in the first place—categorization—is the exact same tool that blinds us.
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$NWBO an asset with published JAMA survival data and zero systemic toxicity shouldn't take over a thousand days to clear administrative hurdles while algorithmic traders short it into the dirt. the system is fundamentally broken. It shouldn't surprise me. But society is failing.
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