Although your title is nominally true it is misleading . About 40% of GBM is mesenchymal, which is more than any other single subgroup but not even a majority of all GBM Also Mesenchymal has the best prognosis (by far) of any subtype so it should expected that they will show better OS. The data proves nothing about DC-Vax (at least not yet)
quick Bailey-- what is the MOA of Reo. Any one of the several ONCY has tried to sell will do. No fair looking it up.
One more UFC cyber head smash while you are on the ground, and I'll leave you to soak in your humiliation- -- From their most recent prospectus
Changes in manufacturing methods for DCVax-L could require us to conduct equivalency studies and/or additional clinical trials. -With biologics products, “the process is the product”: i.e., the manufacturing process is considered to be as integral to the product as is the composition of the product itself. If any changes are made in the manufacturing process, and such changes are considered material by the regulatory authorities, the company sponsor may be required to conduct equivalency studies to show that the product is equivalent under the changed manufacturing processes as under the original manufacturing processes, and/or the company sponsor may be required to conduct additional clinical trials. Our manufacturing processes have undergone "some" ( I would say "some" should read "substantial" but at least one of which is the time they mature the DC's donk) changes during the early clinical trials. Accordingly, we may be required to conduct equivalency studies, and/or additional clinical trials, before we can obtain product approval, unless the regulatory authorities are satisfied that the changes in processes do not affect the quality, efficacy or safety of the product.
What you seem to ignore or simply don't know is that in all pharma, but especially biotech the CGMP process is as important and as hard or harder to obtain as a good clinical result. In fact donkey the pioneer of DC technology used to get his DC's for free from a local blood bank, but the FDA stepped in and said they needed to ensure the quality and put a stop to it. His comment t the time was that there would NEVER be a DC drug because the cost of getting fda approval for the mfg would be prohibitively high. Dendreon ultimately proved him wrong--or did it? Enjoying your crow yet?
well donkey, that is just dead wrong. The manufacturing process has been amend several times and the changes approved by the FDA. That being said, approved or not, it is yet another reason why the FDA is limey to require a second trial even if the results are good
Here ya go --enjoy your crow THESDA, MD, September 10, 2013 — Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has been issued another key U.S. patent (#8,518,636) covering a next generation process for manufacturing lower cost human dendritic cells of both a higher quality and higher reliability.
This next generation system has already been cleared by FDA for use in the manufacturing for NW Bio’s clinical trials. These systems are now in use producing the vaccines which already have been injected into the tumors of DCVax-Direct patients.
This next generation process automates certain crucial stages of the manufacturing process within a self-contained, system. Automating some or all of the production process within such a system can eliminate the need for today’s extremely expensive “GMP” clean rooms (with, for example, special air handling to maintain sterile air in an entire building). Eliminating the special costs for such clean rooms will further enhance product economics, allowing wider margins and pricing flexibility.
At the heart of this next generation manufacturing advance are Tangential Flow Filtration machines, or TFF for short. These machines and associated disposable sets provide an automated, closed system for the crucial stages of the manufacturing process isolating the particular immune cells that become the dendritic cells in the Company’s DCVax products.
Most significantly, the dendritic cells produced through this next generation system, are manufactured using procedures which are more closely related to what one finds in nature. etc.
Oh my god., I feel sorry for you Bailey. But not much. Despite all the evidence to the contrary you mange to interpret disastrous results as positive. Did you ever read or watch Waiting for Godot? Pick it up and give it a read.
There is no hope for these idiots. Panc is just the cherry on top. The p3 in H&N was a complete and total failure. Mgmt did nt even provide OS data. Truly unbelievable. The only good thing about REO is that Pieces oshit teabags like armed lunatic lost a lot of money.
Interesting. At the outset I will go on record as a skeptic of NWBO, however, unlike you, although a skeptic, I remain agnostic on NWBO, and freeze thaw cycling. I agree that knowledge of GBM and DC's has increased exponentially since NWBO began its tortured path to the present. I also agree (although I think it is not that important) that any patent protection NWBO has, is weak. But not because it is old or has been superseded, but rather that, by their very nature, process patents offer vey weak protection. Composition of matter patents are the name of the game in pharma/biotech.
NWBO does not have a "drug". It has a therapy that is process based. They will never have a patent on a specific tumor or molecule. But what they have, which should not be disregarded, is a head start. If (and it's a big if) they get an approved therapy, folks will make money on this ticker. (But the risk reward calc aint what they they think.)
Returning to the issue of freeze/thaw pulsed lysates. I think the jury is still out. The variable that has not been adequately studied is the state of DC's when freeze/thawed. Most studies draw a bright line between mature and immature DC's. But it is now quite clear that there is an intermediate "adolescent" state if you will. There is no clear cut definition or even terminology for this intermediate step. Recent studies seem to support your position that freeze thaw impedes maturation of immature DC's. But there is very little (no?) data on freeze/ thaw lysed "adolescent" DC's. I believe NWBO has professed to have found the "sweet spot" in the DC maturation cycle, which is a narrow window of about 24-48 hours. I don't know that they needed to file an amendment to the trial protocol to make a change to the time they "mature" the DC's
All of this begs the real issue of what will the FDA make of a trial that has been amended delayed, subjected to a vast increase in the knowledge both GBM and DC's in th least 15 yeand has PFS as its endpoint
Yes my little donkey the SEC eagerly awaits emails from morons every day because they get big yuck out of morons who think they know SEC regs. What did your little form say donkey? Give us all a laugh.
Hey donkey --Better get your confederate flag before they are all gone. Don't bother telloin gem you live in Ann Arbor. Most of Michigan is just like Alabama without the cotton.
Just a bit of science to beak up the tedious stream of banal, useless, infantile drivel on this board.
Pseudoprogression was observed in 10 (12%) cases applying the stringent criteria, and in 18 (23%) patients when using the liberal criteria, in the cohort treated with RT/TMZ. Pseudoprogression was observed in only one patient treated with RT alone. The median time to pseudoprogression was 4 weeks after the end of RT. Patients with pseudoprogression had a median survival time of 28 months, compared with 12 months for patients without pseudoprogression
Nice trade donkey. I see aNother tea-pig degenerate will be going to prison. Fox called hastert a democrat so most teapigs prolly think he was. But of corse he was the goop speaker of the house
D2 does not know anything about economists or economics. He doesn't ggrasp the basic concept of sunk costs. The fact that he is down a couple of hundred k is irrelevant to sound rationalthought processes. The only relevant factors are those that lie in the present and the future and the future of oncy sucks by all rational criteria. Ignoring the p3 failure I gave you for free and mg mets dissembling on the results ( which should be a huge red flag) their future has no events that might meaningfully move the stock. The rationalthought would be -sell. Move on. And you'd have the added benefit of never having to read the filth from that teapig armed lunatic.