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Good comments from everyone. Like others, I'm busy right now. The Direct news from today was very uplifting.
The L news was difficult to discern, but I will listen to the webcast at least one more time.
Ultimately, I simply do not believe that people understand Direct will be used on operable and inoperable cancers….period. This places a very heavy burden and responsibility on Linda Power's shoulders.
I think the longs have a nagging feeling they should not mention this (which is not the right feeling to have IMHO). I think the shorts do not mention it because they think they can play this until ASCO (which is greed talking.)
Let's look at a very different example.
Let's imagine Moses in such a dilemma. Everyone has been told the route out of the wilderness is such and such. However, while Moses thinks this may be true, it could mean far more time in the wilderness than followers anticipate.
What Moses secretly believes is that 5/8th of the way on such and such route, there will be a fork in the road. While Yogi Berra says "take it," Moses believes that only then will he be able to determine if he must select the "road less traveled."
Devotees have so set their minds on the planned route that an alternative, even if far superior, will be hard to digest. Moses knows more, but not enough to his liking.
People!!! Linda knows Direct will make L moot if it is as successful as many of us believe. How would you handle this in terms of setting expectations when you have already achieved L access to those who can get it in Germany and Israel (and trials in the United States and Great Britain)? Where would you place your resources, and in what way would you respond to detractors who beat up on L?
Would you pour more resources into the foretaste (L) of the feast to come (Direct) ? Or would you be very careful in setting expectations toward one or the other?
I think this is where Linda finds herself.
We are at the crossroads. Robert Johnson may make deals with the devil, but Linda Powers is instead shepherding us through the storm. Ye of little faith.
Biotechnology is not for the faint of heart.
(Believe it or not, I do not ascribe to a particular religion.)
She would not be able to comment upon a detailed immune response under the ASCO blackout guidelines, that is why I stated a day or two ago that AF would pretend she is using ASCO to "hide" things. Don't fall for AF's inevitable spin.
(See the post #7091...last sentence)
It's good to be loooooooooooooooooooooooooong!
I have video but no audio...I took connections for granted in my current local...oops
Just have a hotel PC w/o sound...
Awesome article. I'm in flight, so I will share a few thoughts later today.
That makes sense. I hope hyperthermia is 'allowed' in combination with DCVAX-L in order to create a synergistic effect in those situations where chemoradiation proves ineffective and/or no longer effective. Ultimately, my hope would be that chemotherapy is taken out of the equation.
I think the point you raised is excellent, but I don't think the data would come from crossovers related to the 33. The 33 were likely all treatment arm, as no placebo had been invented back then. Therefore the control arm knew they were not getting the therapy and typically did not enroll or discontinued.
Nonetheless your point is well taken that:
Olive.
Good points. I agree that a data update will be swift if the abstract is not accepted for presentation.
Recap on upcoming ASCO announcement in a nutshell.
1. If the abstract is accepted, this will confirm the DCVAX-Direct data was mature enough at the time of submission to present at ASCO in the end of May.
2. If the abstract is not accepted, this will enable NWBO to share some data on a date sometime before the end of May.
Either way, it is a win.
My best guess is that MDAnderson's strong feelings about this trial, the potential breakthrough this treatment suggests and NWBO's major investment all point towards abstract acceptance.
(The shorts will frame this by suggesting the ASCO blackout allows NWBO to hide data -- don't fall for the shorts' spin.)
It is conceivable, I suppose, that one day patients might simultaneously have dendritic therapy where one inoculation stimulates part of the immune system to attack tumors, while another inoculation suppresses some concurrent chronic autoimmune disease.
It makes me think about Dr. Vivek Subbiah's comment about cancer therapy moving from chemotherapy, to targeted therapy and currently to immunotherapy. Except with ETAC dendritic cells, the immunotherapy can be used against autoimmune disease.
ETAC dendritic cells might also be applied to Rheumatoid Arthritis, IMHO. Just a thought.
Great article. Thanks John and Red.
I think she was already moving towards marketing. Gliadel wafers should not exist as a GBM treatment at this point. That should be the first competition wiped off the commercial map by DCVAX. Ultimately, 90% (IMHO) of all chemos will be removed from cancer therapy. Let's start with the worst offenders.
Busy weekend. Let me chime in on the immune system question. I'm not going to post research right now (but I have in the past and could post a lot more).
Here is the Reader's Digest version.
GBM patients typically have compromised immune systems even before they receive chemoradiation. Temador is an interesting chemo drug in that it is one of the only chemotherapies that makes it through the blood brain barrier. Fortunately, unlike Glidel wafers, it takes a long time for Temador to destroy the immune system (Glidel wafers do it quickly when it is placed directly into the brain. Despite the best intentions of the person who created this therapy, it truly is a barbaric and horribly abusive treatment for brain cancer patients.) Because it takes a long time for Temador to nearly destroy the immune system, and because Temador is given in several week series followed by breaks; the fact that dendritic therapy helps restore the immune system, and due to the fact the tumor progression itself happens relatively quickly in placebo patients, I personally do not believe this should be an issue that keeps people up at night.
Thanks for posting this BBKing.
And thank you Patriot!
I'm glad to see that you were raised on a fine foundation of prime time television dramas -- not unlike myself. And to think my child prefers reading -- what is the world coming to?
That is the best turn of phrase I've read on the boards. Thanks.
I was just kidding around with the Incredible Hulk reference. It was a response to Doktornolittle's flip.
Yeah man…don't make me angry…you wouldn't like me when I'm angry:)
Afford,
I think the manufacturing expansion, Germany hospital exemption/reimbursement and Section 6.5 plus the FDA-PEI commitment all go hand in hand. Linda just launched DCVAX-L! (In Germany, of course, and this will pay major dividends in the coming months.)
The global manufacturing processes are already approved by the relevant agencies. When you see the forthcoming launch speed(s) in the United States, you'll be glad all this effort went in over the past few years. IMHO.
(Note: And I didn't even mention Direct)
Just a general question.
I'm not talking about today or any day in particular, but what is the likelihood that NWBO could come out with the DMC decision during trading session hours? I'm simply curious.
Ou, I think a site problem is perhaps a little less likely, because Marnix Bosch updated the trial around March 17, 2014, and while one site was added, no sites were removed. IMHO.
Thank You Afford. I have many people around me in my life that care for people like your father. I had cancer myself. My illness closely followed the death of loved ones from cancer. I thought I was, as Linda once said about GBM patients, "toast."
Be you atheist or born-again, the cosmos will conspire to heal what went wrong. Your father's story is in our hearts forever.
May everyones' souls continuously move upward and onward. -- Flip
Fantastic.
John,
If and when the prostate phase 3 trial begins, have you picked up any whiff regarding whether or not they'll use the upgraded version? My sense is that while Linda Powers states it's a matter of dollars and cents for now, there is also the thought in the back of everyone's mind that once NWBO breaks through, the FDA and EMA will understand this technology far better, and this will bode well for upgrading DCVAX Prostate/L/Ovarian in the next wave of DCVAX trials without starting back at phase 1 for everything but Direct.
I know we chatted about this some time ago, but it is a very intriguing possibility.
As you already know, the current phase 3 trial does not use this upgrade, but as you also know, you can bet your sweet bippy that these improvements will only make the entire platform stronger.
Also, even though I do not want NWBO to be bought out if their results are great, the upgraded versions of L, Prostate and probably Ovarian will increase the asset value of the company by a large margin. IMHO.
Great info!
Reefrad said:
Diamond,
We've been speaking a great deal about L as of late. There is also a significant chance for a news update on Direct in the next 7-8 business days.
Agreed.
I just think it is a brief window of negotiation that may close any day do to the imminent DMC decision. It is in NWBO's and Germany's best interest to get it done today.
On the other note, I do not believe enrollment in Germany in the current phase three DCVAX-L trial is possible any more. However, there is no doubt all enrolled patients in the German hospital exemption program will be entered into a carefully monitored data-base. IMHO.
( I could be wrong about the impossibility of German enrollment in the current phase 3 DCVAX-L trial, but if I were a patient, I'd be slightly more selfish for myself and my family. I guess there are many who could be far less selfish than me.)
Interesting point. I had not thought of it that way. Definitely possible.
Yes, I have mentioned the current narrow window allows both Germany and NWBO to be at equal footing during price negotiations, and Germany is the keystone on pricepoint for Europe and ultimately the world. IMHO. If and when the phase III trial demonstrates what we hope it will, NWBO may have too much negotiating power to reach a reasonable price. Therefore Germany should strike while the iron is hot, as they say.
Regarding Ming's comments, I'd just wish he'd stop stating I am certain Germany has the phase three data. I personally think it's more likely than not. He's dubious. The gulf is not as wide as he keeps intimating.
Look at it from the patient's perspective. Look at it from the enrollment perspective. The whole system now necessarily needs a DMC decision. I do not believe anyone involved in the system from company to agency to patient has any intention to mess up the trial, therefore I believe a DMC decision is imminent.
Days to weeks, not seasons.
Be well my friend.
That is the question isn't it.
I would not "unenroll" at this point because, as a placebo patient, I would be moving to the control arm even if I received the placebo much faster than I think anything else could happen.
If I were a patient going to get treatment, I would have been at Dr. Gorter's doorstep up until June 2013. After that, I would have been at MD Anderson for the unblinded direct trial.
Consequently, as you can see, it's probably only a brief matter of time until we learn something from the DMC.
We are going round and round. Let me try something else. John published Doctor Gorter's work on Ihub with dendritic therapy. Gorter lives in Germany. Germany looked under the hood at every nut and bolt of the DCVAX-l manufacturing process in Tennessee (as well as the DCVAX-Direct program). Germany looked at every piece of info they could get their hands on in England and Israel. Germany probably talked to Doctor Liau and Doctor Triozzi. Germany has incredibly smart people in the PEI and the Fraunhofer Instititute who probably collaborate with nearby King's college in England. 3 (some say 2) phase I/2 trials with 39 patient records are available to look at that used DCVAX-L. They looked at Dr. Liau's review of all dendritic work in her 2010 pubmed comprehensive review of almost all the trials performed on GBM with dendritic therapy. They looked at Wheeler's studies and reviews. They looked at Gorter's work within their own country. They examined something like 80(?) patents. They probably looked at NWbio's books. They have a very robust sharing agreement with the FDA to further medical advancement and safety. The DMC allots for ongoing trial information sharing with special privacy guidelines in order to allow companies to pursue licensing agreements. The DMC has very special provisions to allow contact between themselves and the FDA.
Now, take a step back. These rules toward confidentiality and so forth are to guard against "the placebo effect." Guess what? We have math majors on this board, current and former CEOs, Med Students, very experienced investors in biotech, etc. Not one of them can tell you, with any sense of certainty at all, what Germany made their decision based upon.
Now, if you add early phase 3 interim trial data on the primary group in the above list I just gave you, Germany would likely have gone forward with the hospital exemption and reimbursement regardless if the data did not show statistical significance yet. Moreover, neither the DMC nor the PEI likely had access to the pseudo progression group analysis because that group's minimal event number had not been hit yet.
Now ask yourself? Do you think there is one patient in the phase 3 trial has an inkling from the German decision whether they are getting the placebo or not. I'll answer that. No.
Throughout history, science has always been a paradox. It is at once messy and elegant. This is especially true in biology. The dendritic cell probably makes the Roche's and Pfizer's of this world cringe. Why? Because those large pharmaceutical companies where getting very adept at building molecules, encoding genes, and generally starting to make science look like all we need to do is build the right answer. Then along comes this amazing dendritic cell that runs circles around medical science and makes everyone question why on earth they can't do what the Dendritic cell can do.
This is a long winded explanation to state that the process of licensing hospitals in Germany to treat GBM patients with DCVAX-L and reimburse the hospitals for doing so is done to save lives and the scientific process. Science, trials and treatment are not simply mathematical equations; they represent living and dying human beings and the adult balance which must be struck to coordinate several different priorities at the same time. If it sometime seems that your vision gets blurry, welcome to biotechnology.
Or…Marnix Bosch and/or Alan Boynton and/or Anthony Maida might be the folks screened off from the rest in order to make these decisions. Look again at the 4 subparagraphs under Section 6.5 that are devoted to minimizing risk by adding these "firewall" methods without saying the word "firewall." (One does not need to use the word in order to provide for it in the rules.)
NWBO might also/alternatively use a steering committee, but it also could be in-house as I just mentioned. Linda Powers is VERY thrifty (that's why the Lallapalooza at ASCO stands out so much), so do not discount the in-house method. A couple weeks or so ago I thought NWBO was too smart to go without a steering committee; in hindsight, I think they are just as smart to elect either in-house, a steering committee or both.