Oral...yes. However, in 2008, there were approximately 196,000 peritoneal dialysis patients worldwide, representing 11% of the entire dialysis population; 59% were treated in developing countries and 41% in all developed countries. Between 1997 and 2008, the proportion of all dialysis patients treated by peritoneal dialysis did not change in developing countries but significantly declined in developed countries by 5.3%. So, peritoneal dialysis will not account for significant income...hence RMTI is unlikely to pursue this population for treatment with Triferic.
Also, infusion is not dialysis
Ya know abeta,, I don't mind people citing data. I think it important to make this known to the masses who have not scavenged the internet for the information. That being said, if you are going to cite data, you should at least cite the entire dataset rather than skewing your post one way or another; picking and choosing your information is simply wrong and does a disservice to everyone.
Case in point...among the Pancreatic patients you refer to, 3 others died in less than 10 months (3,4 & 9 months) and one other around 17 mo.
Of all the sarcoma patients, 6 others died at less than 14 months (there remains one other still alive at 18 months).
Lets look at one more...mCRC... of the 6 mCRC patients, all others have died. Other than the one you cite, the others died in less than 10 mo; only one lived a bit longer (15 mos).
So your interpretation of the data at this stage of the game i.e. "...Direct will attack multiple
tumors - simultaneously - and the treatment periods will be much shorter ...." is without merit until larger more targeted trials can be run and with the proper controls.
Keep it real.
UR joking, right? Try and force insurance companies to pay for a treatment that doesn't work? And, when they don't pay, would you cough up $125K for something that has not been proven to work?
Just because someone has a few letters after their name in no way shape or form gives them the right to suggest the stupid.
As a point of reference, every single drug that has been subject to PI trials has shown efficacy and hit important molecular targets in non-clinical trials; however, only 12% eventually get approved. That number is even smaller for cancer drugs.
Interesting article in Forbes by Matthew Herper entitled "Nine Explanations For Why The FDA Is Approving Almost Every New Drug Application"
Also the Obama administration has been pushing and may actually have passed legislation pushing for PFS and not OS as the key metric in FDA approvals; however, take a look at another article, "FDA-Accelerated Ca Drugs Don't Get Adequate Follow-Up". You will see that article, that using surrogate endpoints "....as the basis for FDA approval for 36 out of 54 cancer drugs from 2008 through 2012, and after an average of 4 years of follow-up, 31 of all of these cancer drugs still had unknown effects on overall survival (OS) or failed to show gains in survival."
They go on to say, "Reduction in tumor size and the rate of response for these cancer drugs was the primary measure of efficacy for 19 of the 36 (53%) of the drugs that were approved based on surrogate endpoints, and PFS or DFS was used as the basis of approval for the other 17 (47%) of the drugs. After an average of 4.4 years of follow-up, later randomized studies showed improvements in OS for 5 of the 36 agents approved by surrogate endpoints -- one accelerated and four traditional... 18 drugs (six accelerated, 12 traditional) failed to show improvements in OS as primary or secondary outcomes."
Now, what did Dr. Vincent DeVita have to offer that would be any better than what we have today?
The two treatments may also be working synergistically or be additive. Why assume only that it "maybe more effective" in its absence.
Interesting point Buzz. I guess it just depends how one looks at it....potaato...potawto. But the point you raised i.e other combinations, is exactly a point I raised above. If (and again I am speculating here) it is synergistic rather than additive, there could be other drugs that will work better than temozolomide. Given the short life span for patients, a doctor would be hard pressed on their own to alter the protocol and go off label to the extent that (if proven), DCVax and temodar are not both included...but adding a third....is definitely on the radar.
Clearly you are missing the point of proper controls. Copying and pasting the trial guidelines does not change that. I fully understand the need for SOC...I never questioned that; however, as long as SOC is included in the protocol, one cannot possibly tease out effects due to DCVax only. No matter how you argue this point, it is fact. Because of this, SOC must become part of the FDA approval process for DCVax. DCVax cannot be disengaged from it unless it can be shown that SOC is not necessary and that DCVax is eliciting the responses. It becomes combination therapy and not DCVax alone.
So my point, though not sitting well with some, suggests that even though Temodar is the flavor of the day as SOC, it may be absolutely critical and not ancillary, for any positive responses generated when DCVax is involved (though the jury remains out on this question). If you think this is "unnecessary rubbish" so be it. But one cannot dissociate the responses unless studies are conducted to do so.
That's fine. If NWBO generates a successful trial and submits for approval of the combination. But NWBO has never really spoke of combination therapy with respect to the current trial; hence my comment.
We won't know until more trial data comes available and if successful, NWBO submits for approval. Still, as a scientific reviewer, I would either require they submit as combination therapy or validate that DCVax alone is generating the results....there are no other choices.
By the way, my mistake on the spelling.
Give me one place in her entire talk that she said the treatment group only was responding. If you can't, look in the mirror for the moron of the day. I just hate people who choose to interpret statements to their own benefit rather than to take them at face value. I will admit as I noted above, her comments were nebulous...however, that gives no one the right to interpret them to mean only the treatment group was living longer. If so, please explain her following statement, "this is not good for our study". And if you like other believe this is sarcasm, I think I might puke.
Thanks IMG...very insightful. I did not envision the results as negative either....just uninformative. If you will notice, may of her slides were dated 10 years ago. Still, it was a good presentation, but like you, I did not interpret that information as some on this board have.
A huge difference. First, it says that DCVax is not killing the tumor (or at least not to the extent being reported), so any subsequent FDA approvals must account for that alternative activity. NWBO may be forced to show that DCVax with and without Tremodar generates the same results. This is particularly important given that DCVax can and does change the physiology of the tumor cell. Second, if by some mechanism Tremodar is a key factor and not just SOC in effecting the observed results, it is not known if the effects are synergistic or additive. Third and most importantly, whether synergistic or additive, if as I have suggested that the chemotherapeutic agent may be involved, it opens the door for better chemical agents to be tested in conjunction with DCVax....some that may far exceed the activity of Tremodar.
So, it is (or it can be) a big issue. Put another way, what happens if DCVax is approved and physicians start treating with DCVax and eliminate Tremodar altogether just to find that the OS and/or PFS are not the same as observed in these trials.....how will we know?
Keep in mind, these are merely suppositions on my part. That is why I had asked if anyone knew if such data was available. Was SOC part if the PI and PII trials?
Any guidance would be appreciated.
That is one way to interpret it, but I did not hear sarcasm in her voice when she spoke. Indeed she followed by attempting to differentiate between early and late treatment groups rather than placebo and treatment. I think you are reading into things.
My problem was the sound seemed a bit muffled on my speakers and I just could not get a grip on what she said regarding treatment choices.
Also, I have not heard anyone chime in regarding whether or not Tremodar could be a key factor in the responses of those on DCVax.
My interpretation of her statement , " everyone is living longer" relates to ALL participants, not just the treatment group; though I must admit it was difficult to understand completely her statement. About 20:45 into her presentation, she says, "..everyone is living longer...but it is not helping our study..." followed by a blurred statement related to needing larger differences between treatment groups. So I would not be too quick to over interpret her comments. At least that is how I interpreted her statements. Corrections welcome.
Also, I did not see her address here (but maybe elsewhere) whether or not the Temodar is having a larger effect on tumors in DCVax treated patients. Namely, everyone is targeting the DCVax as the determining factor, but could it be that the DCVax is rendering the tumor cells more susceptible to chemotherapy treatment? The current study does not address this. It is possible that a smaller followup study using an alternative drug or eliminating SOC might shed some light on this question.; though this can be difficult to get past the FDA. Anyone see any data relating to this issue?
Maybe I need to clarify a bit. I did not question that journals would publish preliminary data. I questioned the validity of preliminary TRIAL data before the trial was complete. Those are very different animals. The whole purpose for choosing the number of participants on a trial is to eliminate (or at least reduce) variabilities that can surface in trials with smaller numbers of participants. It is my opinion, that most all PI and PII trials even when complete are preliminary because they have not been tested against the masses. So yes, in these cases, preliminary data has been published...but the trials have been completed.This contention is supported in the huge numbers of drugs/treatments/etc. that fail when subjected to PIII trials.
I for one have never seen where trial data was published before the trial was complete. If it is/was, I would seriously question the referees, the editors and the journals that published the garbage.
That being said, I have also seen preliminary data where the trials were complete but where after the work was done, additional questions were raised and needed to be addressed by additional testing thereby making interpretation of the data preliminary. But these were still based upon a complete cohort of data and not a subset of data.
It goes without saying, that if Bosch was in the process of writing a paper back in November and long before the trial was complete, it indicates that the paper was based upon data already available and not on data yet to be generated. How does one write a paper before they have the information? I imagine that he is also writing a paper on the outcome of the 2016 Superbowl. He would have just as much luck on that one.
No journal will accept a paper until all the data is in and been properly scrubbed....blinded or not. This is fine for an abstract to be presented at a meeting, because these are considered preliminary data anyway; however, it will not fly for a peer reviewed journal. So, don't expect any paper they may be writing to include information from a trial that is not yet complete. It makes no sense.
Not sure if anyone is keeping up on the Cell Biology portion of GBM, but the info below is rather interesting. At this early stage of the game, it is difficult to ascertain how immunity will play into this long term. Researchers will present their work on tumor self-organization on Dec14 at the Annual Meeting of the American Society for Cell Biology.
"Brain cancer is not anarchy, say researchers but highly organized--self-organized. Researchers report that glioma cells build tumors by self-organizing into streams,10-20 cells wide, that obey a mathematically predicted pattern for autonomous agents flowing together. These streams drag along slower gliomas, may block entry of immune cells, and swirl around a central axis containing glioma stem cells that feed the tumor's growth."
"Lowenstein and Motsch mapped out this dynamic picture of glioma self-organization by building and comparing two model systems, one biological and one mathematical. The living model system was built in vivo using mouse and human glioma cells genetically tailored to express a deadly package of genes known to spur development and progression of brain tumors. The observed movement, distribution, and invasive nature of the resulting streams of elliptically shaped glioma cells were predicted by their mathematical model, they report. Assuming that the glioma cells were independent agents, the mathematical model took into account adhesion and repulsion dynamics between tumor cells. The results showed unmistakable signs of non-random, self-organization of brain tumors..."
"Most striking, the presence of self-organizing structures was not related to any specific cancer mutation. These swirls eddied around cores of glioma stem cells that (was described) as possible nucleating centers for brain tumor growth. The in vivo model also produced glioma cells organized as individual spheres, including some that set ...adrift in the cerebrospinal fluid..."
Almost like early stem cells.
Given that as stated above, we are in the first year of a 7 year contract, it goes without saying that "shopping around" is a moot point. However, I am surprised that this was not entertained early, before the signing of the contract, if for no other reason but to advance a better deal with Cognate. But then again, when you have the chief stockholder of Cognate being the BMOC of NWBO....what should we have expected???
As for 'starved for information', I think that Linda learned her lesson long ago about releasing anecdotal trial data. With reference to the other trial(s), NWBO simply does not have the information to release given most are double-blind. Those data from early trails that involve few patients spread across broad disease lines is of little value from an interpretive point of view...at least not enough upon which to make investment decisions.
Finally, many on this board got used to constant updates, but the company was lambasted for it. The only tidbit of information I would like to hear about is reason and progress on the halt in enrolment. The rest is...well....it is what it is....a game of hurry-up and wait.
The bigger question in all this is why should any of this matter? Cognate is simply a contract manufacturer for NWBO. At least in theory that is all they should be. No investors in AAPL seems to care that QCOM (who makes some chips for AAPL) is now being called out on improper pricing practices....but maybe (and I am just spit-balling here) the link between NWBO and Cognate is so integral, that it borders on the improper. As such, news on Cognate is now having an affect on NWBO and is now taking center stage when discussing NWBO. Doesn't that seem odd to you? It certainly does to me!!!
Why should this news on Cognate even matter to NWBO investors? I have maintained that of LP was a decent CEO, she should have been pursuing other manufactures in the first place rather than paying inexplicably high fees to Cognate. I surmise that the high costs were needed to pay for Cognate's need to upgrade their manufacturing facilities and produce DCVax. The last I saw was that Cognate's annual revenues are about $2-2.5 mil (most of which emanates from NWBO to be sure). In essence, NWBO has been funding the expansion of Cognate rather than just paying for the costs to manufacture DCVax. This involved a 7 year contract and we are still in the first year of that contract. So one can expect ton's more money to flow in that direction over the next 6 years (or 5 years after the first commercial launch of DCVax).
With this recent mess, don't be surprised to see more of NWBO's money funneled to Cognate in order to cover their legal fees and the losses from these court cases. Assuming my numbers on ann revs are correct, I am not sure where else those moneys will come from.
This is getting to be a real sham and taking our eyes of the ball...i.e. does DCVax work or does it not???
I am not criticizing this thread, more so just wondering why we should be worrying about this type of legal activity if it does not involve NWBO, but a subcontractor of NWBO?
The correct approach would be for NWBO to put manufacturing out on competitive bidding and find the company that can manufacture the product(s) at the most economical price. Quality is not an issue because each and every production of DCVax (inasmuch as it is custom made) must go out for quality control and certification. So this would be required of any manufacturing company.
To date, the manufacturing costs charged to NWBO have been nothing less than exorbitant;. My questions to you are, don't you think that under normal circumstances, any CEO of NWBO would be inclined to seek out the best price for manufacturing? Do you think this is in the cards for Cognate and Linda Powers? Or do you think that the manufacturing arrangements between NWBO and Cognate are now set in stone?
Aside from the medical aspects of the product, NWBO is beholding to the stockholders to seek out and determine if there are better less costly manufacturing alternatives. I for one do not see this in the cards for Cognate and NWBO because of Powers. Because of this, and because of the tens if not hundreds of millions already paid to Cognate, your estimates of 15%, 20% and whatever, are not at all supported by past pricing and charges imposed by the NWBO/cognate arrangement thus far. So why should this price gouging change going forward benefit NWBO rather than Cognate given it has not done so as of yet?
I am much the same. I sold most of my position in back around $10 +/- and have been looking to get back in...but will wait a bit longer; maybe after the dust settles a bit on the Cognate issue and after resolution is obtained on more financing which is still not resolved...Woodford was a patch, not a solution.
I also got bit on Keryx. I sold at a big profit back at $15 but got back in when the price dropped...unfortunately I got back in before it settled at its current price....but fortunately not too many shares.