Think of it this way, further:
Safety issues cause full halts.
This was a “partial-halt” without clarity as to what exactly that meant, we can only see the result at the end, fewer placebo patients.
If it was a safety issue having to do with giving DCVax, then why were all the patients receiving DCVax still getting it and still starting to get it? Those would be the partial patients you’d halt, except when you halt giving the drug to your, you don’t continue adding patients whenever they “enrolled”, placebo or otherwise.
Furthermore, with a safety issue, doctors, patients, everyone needs to be notified and the doctors are not “on the side of the company”, they are doing their duties as doctors, so they are not going to hide what that was about in a journal article. It would be fully disclosed. It was not there. All of those doctors and institutions they work for would be involved in a major fraud? That would be completely bananas and factually unlikely.
And as I said, it would have necessarily been disclosed in the lawsuit, and that motion to dismiss would likely not have been granted and if even despite that granted, the judge would have had such material facts in the opinion.
I do not think people understand the limits of discretion and confidentiality here or that they’d not want to be in a company that kept such major facts secret. Which I do not believe they did, I think they said what they knew or they’d be in trouble, and LP and LG know that clearly, quite well.
Yes, the PFS was the wrong measure, most likely because of pseudoprogression. Crossover caused issues too, and then the almost arbitrary result of the conflict of laws here, led to the reduction of the placebo arm.
No one is going to convince me that the regulators will not do what they can to make this a valid trial for any number of ethical and legal and constitutional reasons. And further, assuming the results on survival are at least as good as the interim article compared to what is commonly said and understood to be the case with GBM patients under the current standard of care, it isn’t personal conclusion and belief that it will be very difficult for the regulators not to approve based on those results, but the primary issue that has concerned regulators over the years has been replication of a quality cellular product, which appears not to be an issue here generally, and is similar to those for Car-T, and manufacturing at scale, which would make regulators much more enthusiastic.
I think the company is well on their way to resolving those issues satisfactorily as well.
I don’t agree that Flaskworks merger was set in stone when likely the various people may have been in touch, though I do think it was always thought if Flaskworks worked, NWBO would be a major customer. But events worked out so that the fate of the companies was inextricably intertwined and there were not enough customers yet, that it made the most sense that NWBO simply buy the company and work to advance the technology even faster, which I have said many times I think will be the result and the end will not be discrete machines but a much larger process in a factory that uses the space most efficiently to manage the manufacturing. Initially they will go the simplest route, to get certified for Flaskworks, but eventually, this company’s manufacturing, just from what I know about recruiting manufacturing engineers many years ago, will be much more complex and higher tech even than that if DCVax is a success, which I expect to be the case.
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