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Wednesday, May 15, 2019 12:24:30 PM
The delay and the shareholder support for delay is ridiculous. I guess it means mgmt and/or you has no faith in success with today's data. Also, if successful the delay for -L has been delaying every other trial and offshoots and permutations that could be exploding the boundaries of DC treatment. The complexities and other bullshit listed in Cherry's repost of ASM meeting read like a laundry list of excuses for someone to NOT get the job done.
First; I don't begrudge good people for being frustrated in NWBO's case. However, I do believe if people are truly invested in this and want patients to be able to have the treatment AND want to find some monetary success from their investment they have to be rational. It's irrational in my perspective to wish for something to occur that cannot yet occur. And I find it further irrational to believe there is some reason that is not meaningful to delay any of the tasks that are going on to finish the trial, collect the data, finish the SAP, unblind the trial, and file a BLA. What would that delay be if not meaningful? Could anyone please state this clearly? Who would knowingly delay a trial that is showing amazing blinded results if not for a really good reason? Why?
Cancer patients don't have time. I know that very clearly, I deal with it all the time with my patients. That does not mean it's rational to turn that desire for being helped by this technology into verbal punishment to those who're trying to make sure the treatment gets approved. They have discovered a lot of information about different genetic markers that may have a prognostic factor as to who does well with DCVax, yet because the trial is still blinded they cannot make that assessment yet. So they have to develop an SAP that will encompass these possibilities/probabilities. To do that you have the scientists conducting the trial giving their allowably known data to consultants who're pouring over this data, developing a pathway, and re-checking with the trial scientists to make sure that pathway is what they too consider would prove efficacy. There are many, many of these pathways, all of which could in combination or individually lead to approval. I guarantee you this; Carl Rago understands this very clearly and if you read his paper you can find that same understanding and can see, also clearly, why this process is a long and careful one.
Trying to turn one's frustration, without a rational reason for claiming foot dragging on NWBO's part, into anger directed at the company is just mind boggling to me. This could be the platform for an incredible new paradigm in treatment for all cancers, and be the stepping off point for all kinds of combinations individualized for not only different tumor genotypes but for different types of cancers. If NWBO management has given the idea that results were just around the corner for too long I agree that's reason to be frustrated and to criticize. But, in the face of what's been shown so far, form Linda Liau's presentations, to the publication of blended results, to Dr. Rago's paper, and to Dr. Ashkan's statements in the UK I think everyone needs to put this in perspective and try to relax and let it come when it's ready.
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- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
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