BTW Feurerstein is simply wrogn when he say OS must be doble blinded--From the fda webstie Guide to the IndustryTable 1. A Comparison of Important Cancer Approval Endpoints Endpoint Study Design Advantages Disadvantages
Overall Survival • Randomized studies essential • BLINDING NOT ESSENTIAL
• Universally accepted direct measure of benefit • Easily measured • Precisely measured
• May involve larger studies • May be affected by sequential therapy • Includes noncancer deaths
Do any of YOU know what you are talking about? You took some information off of the FDA website that is very much out of context. This whole board is going off the deep end here and all of these posts are arguing scientific terms without understanding the concepts behind the terms. This is like watching 2nd graders arguing on the playground. Forget about the "double-blind" method of drug study, who has a competing therapy, how much funding is coming from some company that no one really knows anything about and what price the stock is posting on any given day of the week. Does the therapy work? NO. Also, their reports of their studies are horribly inept and there are serious questions about presentation of their results. This is information taken directly from NWB's website:
"84% of patients who received DCVax(R)-Brain in these trials have so far lived longer than the median survival of 14.6 months under standard of care"
Now, does that mean lived longer than other people up to that point, or lived longer because of DCVax? It is obviously not clear. In addition to this, 84% of 19 people is 15.96 people which is way to small of a study set for compelling results and NWB probably should not be broadcasting that they are proud of this--peer review is extremely vicious and unforgiving. Also, the patients were receiving chemotherapy at the same time--which is what "concurrent" therapy means. As of May of this year they still only have 33 out of 240 potential study entrants for DCVax-Brain and this is only a Phase II trial! There is just too much bad science and sloppy management here to warrant any serious faith in this company... they just dropped the ball too many times and this "next time is gonna be so much better" modus operandi has been way overused. How much punishment do you want to take before you call it a day? The bid/ask spread is ridiculous and I'll be extremely fortunate if I break even when I dump this train wreck. You all can keep arguing useless points but it won't help.
Questions of technical credence from unidentified MB poster, PLEASE!
Lead investigator Dr. Linda Liau presented at the ASCO annual meetings in 2007 and 2008, and published in the New England Journal of Medicine in July 2008. Reported receiving research support by Northwest Biotherapeutics.
You make some good points but the fact is that in clinical trials with humans new treatments or treatment combinations will be compared to standard of care. No way around that. The present results from UCLA are not strong enough or adequate to support product approval but do support the concept that more work should be done which is what NWBO is supposed to be up to. The phase II trial is powered to be pivotal meaning if the results are good it can be used for approval. Orphan drug designation allows some shortcuts.
That said, your review of NWBO's incompetence is completely correct but is also only the very tip of the iceberg. The purpose here seems really less about helping cancer patients and instead about creating an illusion that can be leveraged into allowing Toucan and associated insiders the ability to break even (or nearly so) when they, as you say, dump this train wreck. You have company and Toucan cares nothing about anyone but themselves.
A good question for the current crop of newbys and hypesters who come and go with great regularity is what value does NWBO really provide that no one else can provide? The answer is nothing. In fact, development of this product would be much easier and faster by starting over with a clean slate and competent and determined management.