An agreement would be nice...maybe it is in anticipation of launch. Remember "buy on the rumor sell on the news". Now would be the right time to be getting in if one believe Triferic will be a success...the stock is not far from its recent lows and it has been languishing in the $10.50 range. So a push upward is encouraging. For me, I would feel more comfortable if that volume was sitting at 1-1.5 mil.
Soft, it is nothing to sneeze at to be sure; however type in NWBO as example. This is a stock that is up 6% today (intraday high of 8%) but on volume of 1.3+ million rather than its norm which is 575K. So, something is indeed going on there. Here (RMTI), it is a good sign that the volume is at least normal, but that also tells me the spike could easily be attributable to daily fluctuations rather than any catalyst. I guess we will see in a few days how this shakes out.
All good signs, but not yet confirmed with volume which is a key factor that makes the other indicators work. We have traded above $11.00/sh 5 times since Feb 26, but like today, on mediocre volumes. In each case, they subsequently retraced. Like I said, it is a good sign that there is life in this stock and it is not afraid to go higher, but we just need a catalyst to keep it there. Not yet sure what is driving the stock today.
The 51 patient Information arm was not part of any blinded trial and their data will not be used to support the ongoing trials. This "information arm" is akin to the approval in Germany...i.e., how can it hurt??? These patients exhibited evidence of early tumor re-growth following weeks of radiotherapy and chemotherapy and therefore failed to meet the minimum qualifications for inclusion.
One has the right to question the ethics if releasing this data if that is what AF is intending in his accusations. Also, releasing this information while a trial is ongoing is probably not the best idea because it can provide a false sense of hope or failure to the patients that are on the trial. I am a cancer survivor and one thing I learned after numerous surgeries and 2 years of chemotherapy is that mental attitude has a lot to do with overall health and recovery...and who knows maybe even survival!!!??? That being said, there are absolutely and positively no security laws being broken here as he portends. He is just pi$$ed that the stock has performed well and his most recent attack did little to quench the current enthusiasm and trend in the stock price.
I tend to concur. My fear is that Direct will not reach the "perceived" endpoints. I do believe that the safety profile will be fine; however, this is a combination PI/PII trial which means response will be a key parameter as well. I think the expectations are a bit more lofty for Direct than for "L" only because the data is due first. That data will be perceived as a preface of things to come with the "L" trial. So, if I am correct and the results are equivocal, the $64000 question is, what happens to NWBO stock price between data release for the Direct trial, and the data release for the "L" trial ???
This industry has a low threshold for equivocal data. This was demonstrated by IMUC wherein the subgroups were small in size, and not powered to show statistical significance. Even though they claim that patients treated with ICT-107 generated large and clinically meaningful results, the long and short was that the trial was considered a bust. The stock has never recovered since that time (Dec 2013). The direct trial was set up to generate similar data i.e. too many tumor types and not enough patients in each arm of the trial. I understand the Direct trial was designed to determine if there are one or more tumor types for which Direct has a predilection for treating. That's fine, but I am just not sure that the small number of patients in each arm will be able to adequately answer that question given the range of responses one can expect.
I guess time will tell.
Lets look at some of your intelligent posts in the last week or two...shall we???
"jk4763 is a paid basher-on iggy he goes"
"cheating_stock _investor is laughable. He says he posts here for pure commentary"
"Greatday-Go FC yourself.thanks"
"gumshoeishere is a paid basher-on iggy he goes"
Huston we have a problem. Not sure you can amass a cohesive thought other than for "...XYZ is a paid basher..."
Just once have something informative to say because your opinions are unsubstantiated. You seem to be this person who likes to bash people and who gets their rocks off on the one or two who agree with you ( probably nothing other than aliases of yours posting positive responses).
Anyway, enough said, if you don't like reading intelligent posts, just put me on ignore. But please, please, do not pass yourself off as someone in the know....or even as an intelligent investor...Hmmm now that is an oxymoron "...intelligent investor...youraunt65..."
Seems to be the flavor of the day. I believe in the technology, unfortunately, the information presented as yet is not much to hang one#$%$ on either way. Compelling, yes, but that is as far as I can go. Patience is the name of the game for now.
#$%$. If you do not have the wherewithal to read and evaluate an intelligent post, don't blame it on someone else. Go back to grade school and get an education. You are like many others that blindly go along with the masses. That is your fault. If you do not know the difference between scrubbed data derived from a verified trial and anecdotal information...you should not be investing in bio stocks.
I don't necessarily disagree with your comments. I have said many times that AF is a pimp...nothing more but maybe a lot less.
That being said, this is the problem with releasing anecdotal information that has not been generated within controlled limits and been properly scrubbed i.e. the trial. AF decided to "reclassify" some of the patients arbitrarily. Because they died prematurely (based upon the norms), he used this as support to reclassify them. Unfortunately, no one knows to which category they should be classified....it is left to interpretation and the sky's the limit. He is not right to reclassify patients to support an argument and then pass this off as truth. That being said, we simply do not know if in fact these patients were indeed rapid progressors....no one knows...that is why they were not included in the trial. So on this specific point he is neither right nor wrong...so take it with a grain of salt.
There is one thing he said with which I can agree. Inasmuch as these patients fell outside the purview of the trial, attempting to glean any meaningful interpretation of the data is for not. I have been saying this since day one when Linda started talking of one patient here, one patient there, 5 here and 5 there. The same will happen when information from Germany comes available so be prepared.Those on this board getting upset just need to let this thing rest. It will blow over. The real data has yet to come forth. Until that time, it is all smoke and mirrors.
I posed this earlier this month in response to someone else's comment about " 8 days":
"That is not entirely correct. The "manufacture" time is as you indicated approximately 8 days; however, after the lysate is made, a special blood draw (leukapheresis) is required. Unlike acquisition of the tumor which can be stored frozen, the blood must be obtained and kept "fresh" and processed within 20hr of acquisition. So timing is everything and this can provide a huge bottleneck to sample processing as the numbers of samples increases. As such, it could require a patient to wait to have the blood drawn so it can be immediately processed when it gets back to the lab.
Finally, there is the quality control issue. Once everything has been acquired and the vaccine produced, there is an additional 1-1.5 months that it will take to perform the required QC (not sure if this has been shortened in recent years). I also do not know if this is specifically related to the trials or not; however, I suspect that this is part of the normal protocol. Inasmuch as I do not know what that protocol involves, I cannot help but to surmise that substantial culturing for infectious agents will be part of the QC as well as some PCR for others.
So, unless they can substantially eliminate the perceived bottleneck and the required QC, we are looking at a minimum of 2 months from the time the tumor is obtained....not 8 days."
The issue of quality control was stated by Carol Powers, patient liaison for NWBO.
Also, it makes sense. When drugs are synthesized, each batch is required to undergo QC. In this case, since each is a "custom treatment," each preparation will require its own QC.
It takes 8 days to produce and up to 5 weeks for testing and validation. Add that into the surgery and other minimal in between times and you come up with 2 months (more or less). That came from the horses mouth i.e., NWBO.
As noted in another thread, both treatments ( if successful) will have application. If DCVax does prove to generate a systemic response, this, as you indicate will be a good long term treatment; however, this has not been validated in any way to date.
I also believe that the poliovirus will require that each tumor be injected. But you must see the benefit of such a treatment (poliovirus) i.e., not a custom treatment, can be mass produced, rapid, single treatment.
I agree that additional research may need to be done (I suspect it has already been done) to show that the virus itself has a good safety profile. My big concern would be the potential for reversion to the virulent state and loss of specificity for the tumor cells. However, before the FDA would permit the PI trials to proceed, they required 7 years of primate testing to validate safety only....and the attenuated virus passed those tests. The safety issue at hand is not the virus itself but the host response to the virus which I believe will eventually be shown as controllable.
The woman they spoke of last night who died due to massive inflammation also dropped out of the trial during this stage of the process. Who is to say that this could not have been addressed/controlled by the Duke team had she remained on the study and been treated by those in the know???
We will never know.
Again, at the moment, there is no definitive evidence that the response to DCVax-L is systemic. This is what I mentioned in my first comments. Even NWBO has indicated on multiple occasions that they are considering injecting multiple tumors. Why would they be entertaining this idea with a response that is systemic?
Also, all treatments are directed at patients with a very short life expectancies so the safety profile for the poliovirus is immaterial. Be that as it may, after the polio virus PI trials, the issue will be moot.
Clearly, swelling is a problem, but I suspect it relates not only to the amount of the poliovirus, but equally or more so to the size of the tumor. The larger the tumor, the more opportunity for higher replication numbers of the virus which in turn will generate more explosive inflammatory responses. So subsequent studies will probably center around investigating the relationship between tumor size and viral load administered. An algorithm will be developed should the treatment proceed to its logical conclusion.
In several pieces of information we have been presented thus far, it has been noted that the size of the tumor in DCVax treated patients either did not shrink initially, or actually increased in size early on. It is likely that this was due in part to swelling and inflammation. The response in DCVax is just not that robust or fast to cause the inflammation seen with the poliovirus. Still, I see this as a controllable outcome of a well defined treatment protocol.
Well, that is the basis for DCVax-direct; however, the mechanism is much different between the treatments. Nearly all solid tumors contain receptors for the poliovirus...sounds strange but indeed this is the case. So as I understand it, the virus gets into the CA cells and begins to replicate. It then breaks down the outer "coating" that protects the CA and the host immune system mounts an immune response actually against the virus; the CA cells get wiped out in the process...possibly due to the inflammatory response.
Not sure how one can claim " inferior" at this early stage in the game.
- no definitive evidence that DCVax works systematically either
- DCVax-L requires a surgical procedure to remove the tumor to generate sensitized DC cells, 2 months worth of work and testing to generate the treatments, and up to 6 injections
- Like any treatment, dosage must be determined empirically. If you don't think so, try ingesting a bottle of aspirins and see what happens!!
- with any treatment, long term is an issue; the same as with DCVax until long term studies indicated minimal side effects.
The reality is that this methodology using a modified poliovirus could be a remarkable addition to the arsenal of anti-CA treatments of which DCVax (with any luck) will become a part. Accept that possibility. You are looking at it from an investor point of view...I am looking at it from a patient point of view....which do you think matters the most???
Might want to qualify and say you can change the form factor and "test" it on others. The benefits and loss/reduced toxicity revolve around long term dialysis using microgram quantities of iron in the dialysate. Over a 3-4 hour period, the blood volume that passes over the dialysate is in the neighborhood of 1200 liters. So small amounts of iron over long periods of time are what works. To simply imply this can be adapted to IV treatment is unsubstantiated. Hence the new trial. But this is far from being a slam dunk.
At this stage i.e. PI trials and with very few patients, no one can glean anything from the information on using the polio virus other than it shows promise. Of course there are probably tons of information to which we have not been made privy. That being said, these treatments were a single injection with a virus that can be mass produced so there is no "custom treatment" and no wait time like DCVax which requires up to 2 months between initiation of the procedure and treatment. With a tumor that doubles in size ever 2 weeks (recurring GBM), that is a ton of time. It also implies that the costs will be substantially controlled since it seems not to require initial surgery...this was merely done on these patients as the normal course of treatment to be included in this trial.
Still, as with DCVax, treatment with the attenuated poliovirus raises some questions to me and that is the issue of a systemic response. It appears with the poliovirus treatment, that each tumor must be injected because there is no systemic response. The immune system attacks the virus and in the process attacks the cancer as well. This implies that with early stage CA i.e. non-metastatic, this procedure may have promise; however, with metastatic and disseminated CA, each and every tumor must be injected. This is information that I have been looking for and will be looking for when the DCVax data is released. If truly systemic, there should be no reason to inject/treat multiple tumors. We have only been provided anecdotal information on this issue to date and it has been vague at best.
Unfortunately, I think this is more the norm than the exception. Many will sit in the wings awaiting public articles on the subject or input from colleagues before diving in with both feet. That's fine, but they should not chime in on scientific and medical implications unless they are better read and better informed. Granted, some do keep up with these matters, but the comment, "...(it) has not been proven effective or safe..." did not come from such a doctor.
I think they will come to appreciate the benefits of Triferic....we all just need to be a pit patient and hope the estimates are not too lofty...at least initially.