I guess that is another way of looking at it, but we are coming to the same conclusion...in its current state, who else would want it; who else would be willing to fork over the money for what has been and continues to be a loosing proposition.
It is a shame that one must separate the science from the investment, but in the end the two are not always mutually exclusive i.e. NWBO.
Without some positive influence, it will be impossible to generate additional capitol. NWBO will have no choice but to reverse split. But even with a RS, the trendline has been so strongly negative since July 2015, it will still remain difficult to generate new capitol. There have been some mild spikes during this time, but the downward trend has remained intact. Plus, big time bio investors are not stupid...they see the problem with LP and Cognate and this is scaring them off (at least the ones doing their proper DD).
How bout this one for a spin....don't be surprised if LP is "situationally" forced to have Cognate invest money back into NWBO to keep NWBO afloat. I find it hard to believe that there is free money out there for a penny stock, or for a stock whose share price has been artificially inflated by a RS but been on a consistent year long decline.
No offense Frank, but what are you expecting at ASCO that has not already been set by precedent i.e., nothing new ever happens at ASCO w/r/t NWBO. Late braking or not, NWBO cannot for the first time disclose information at a meeting that has not already been disclosed to its shareholders. So generally these meetings (again with respect to NWBO) are only presenting data we already knew about, with maybe some clarification of finer points.
Every year investors get all excited and look for some landmark event or information from NWBO at ASCO and every year investors get disappointed. Well, let me prognosticate a bit...nothing material will b presented at this year's meeting, next year's, the years following, that we have not already been made aware of prior to the meeting.
Now, I will admit that this does not preclude preclinical data from independent researchers; but this is not what you are looking for. ASCO may at one time have been relegated solely to clinical trial data, but it has morphed into a general society meeting on Oncology and this includes preclinical data as well. So if that is what you are expecting...it is very possible that preclinical data on DCVax may be presented. But don't hold your breath for previously undisclosed information on the current DCVax trials.
The only part of LPs activities that have me baffled is her intimate involvement with Cognate. This is problematic no mater which way you try and spin it. Also, someone's resume will not create a viable treatment. Whether or not DCVax works will in no way depend on where LP went to school or what her managerial background looks like...or any of the researcher either. All of this is hypothesis driven research on a disease that is not well understood.
What baffles me is that everyone tries to blame the FDA for the plight of NWBO. If memory serves, the halt on enrollment occurred simultaneous with, or in a very close window surrounding, NWBO's announcement (Liau's video) that all treatment groups were living longer in this trial and that this will complicate data analysis. When I heard that, it made perfect sense for the FDA to halt enrollment...like it or not.
I will admit that I am speculating here, but why would the FDA allow the trial to continue unencumbered when, by their own admission, NWBO basically said that they may not be able to gain any information from this trial? So the FDA does the only "humane" thing available to them....they allow those on the trial to continue on the trial because the danger to them is minimal, but halt adding new patients to the trial because the final end point may not be interpretable. The onus is now on NWBO to prove to the FDA that it can handle the unexpected snafu...which they have not yet done.
So with more speculation, I am going to say the FDA will not allow the enrollment to continue until NWBO can demonstrate that they can deal with this dilemma. On the flip side, NWBO cannot demonstrate they can deal with this dilemma until the trial, with its reduced enrollment, progresses to time and patient adjusted endpoints, and that NWBO can make sense of the data. Until that time comes, do not expect the FDA to reinstate enrollment into the program.
NWBO tried it the other way; letting us know what was happening with each and every patent. That position blew up in managements faces. They were criticized by just about everyone. So, in my mind, they made the smart move. They are not going to tell a story until there is a story to be told...and right now there is none. All the other information is just smoke and mirrors.
When you link this data to the recent information on the expression of the NRLC5 receptor, the take home is that cancer cells have found ways to escape immune recognition and therefore enhance survival. In the case of the virus, there are poliovirus receptors independent of CA that can be used to target CA cells. The virus binds receptors and enters the cells. I suspect that when the virus makes proteins, they become surface bound which allows immune recognition and attack by the T cells. In like manner, it was found that the NRLC5 receptor is elevated on normal cells but is substantially decreased on CA cells which prevents or hinders immune recognition.
The down side to the poliovirus issue and which may in fact be the same with DCVax, is that the virus does not replicate so when the cells burst, that particular tumor is dead, but in order to get the other tumors, one must then inject each tumor separately because there is no virus circulating in the system. In like manner, there appears to be a poor systemic response with DCVax. The antibodies and T cells are elevated and it is leading researchers to believe that the response should be elevated as well, but NWBO does not know if the specific GBM killing T-cell response is the same for the distal tumors. I believe that the T cells specific for cell death of distal tumors maybe distinct and therefore lacking. This is supported in interests and efforts by NWBO to begin injecting distal tumors. It then becomes analogous to the poliovirus.
Correct Jerry. The bigger issue looming and that may come to fruition as soon as next week (given the current rate of share price deterioration) is NWBO being in violation of SEC rules regarding bid prices below $1/sh. Granted, NWBO might have as long as 6 months to get their price back above $1/sh, but without positive trial data, this will require a reverse stock split. Generally, it is not a 1:2 reverse split but more like 1:5 or 1:10. Unfortunately, without some data, this will just provides more room to fall rather than buying time for the trials to complete.
I guess we will just have to watch and see. Even coming close to this will cause difficulties for NWBO to raise more funds. If this is even in their plans, they will have to reverse split sooner than later in order to be able to raise money if and when needed.
Right now all they have is a relationship. There remains as yet, no causality in the discovery. They know "why" but do not know "how". No "mechanism" has been identified that causes cancer cells to evade the immune system; only a marker (NLRC5) that will help the patient and the doctors know if the CA can be more easily controlled. In a nutshell, if the NLRC5 gene is elevated, it suggests that the surface receptor is also elevated which means the immune system will be able to recognize the CA cells and assist alternative treatments to control the cancer. If the NLRC5 gene is reduced, it means that the receptor will not be visible to the immune system and the CA will be able to better evade host immune mechanisms. Control will have to rely heavily if not solely on the treatment regimen.
The interesting thing is that they may have found at least one link that addresses the question why some patients respond better than others to treatment; namely, patients responding positively to treatment are likely receiving help from the immune system. They are just now looking into ways that might regulate the activation and/or expression of NLRC5; but they have no idea how this will work because it is also expressed in normal cells. The researchers state in a nutshell, "We hope that in several years, our research may identify potential drug candidates that can increase the levels of NLRC5 and thus help our own immune systems better fight the cancer."
So in the answer to your question, if anything, controlling NLRC5 might help DCVax, not the other way around.
Titus, I can certainly appreciate the frustration. That level hit me a while back so I bailed when the stock was at $9.40 last August. I have been looking to get back in ever since but the stock has yet to make a serious effort to change directions...so I continue to wait.
The risk you refer to i.e. the patients, is indeed the key issue here. The idea of "fast tracked" relates to an FDA and approval matter. At the moment, the science is not yet completed and that is something that cannot be " fast tracked". You already have this treatment as a "cure" and FDA approved before the data has been collected and scrubbed. This is precisely the confusion that is generated when premature and incomplete information is released by the company. The data is promising, but it is far from comprehensive or from being validated.
I am not sure what you mean by, " I am suspicious that things are artificially suppressed by those that will lose a lot if this treatment is successful." First, and lets be clear about this, DCVax may one day become the primary treatment for GBM; however, given the genetics of the cancer and the variability that can and does exist between patients and indeed even among tumors within a given patient, I think it is overly optimistic to think that even an immune approach will generate a unilateral "cure" for this disease. Preliminary information from NWBO supports this conclusion. The results are very promising but far from all inclusive. Second, this is high risk research and on a very complicated disease that we do not know much about. It is overly optimistic to be thinking of anything other than a treatment. Finally, you have to give the science time to work. Rushing this can just as easily work against final approval as it could to promote final approval, but more likely in favor of the former.
I would wish you luck also, but it is not about you or me now is it??
Lack of communication, short selling, negative articles etc. are not what will sink this company. There is only one thing and that is a failed trial. You are linking your emotions on investing in the company, to the scientific component of the company. In the end, if the data is good, all that concerns you will be moot...guaranteed. If however, the data is bad, no amount of good communication, positive articles or loss of short sellers will change the inevitable. Better communication of no information will not change the ultimate outcome of this company, either way.
I for one am quite glad that the company has made the decision to keep their mouths shut. The publicity they generated before only opened themselves up to criticism because the information they were providing was anecdotal as it related to a positive trial outcome. You can always find one patient here or one patient there that blows the curve, and that was all they ever discussed; individual cases. This approach came under great scrutiny because smart investors started to ask "what about the rest?" and it turned into the blood bath we are seeing today. So NWBO learned to keep a lid on it until they have something to crow about. Smart move I say!!!
As for things going on in Germany (for example)....no news is......no news. Nothing more; nothing less. I interpret the lack of news as being that there are uncontrolled issues ongoing overseas that have yet to be worked out. Is that what you want to here? Why state the obvious? If there is a material issue i.e., cost negotiations broke down, or deals have been signed and implemented, SEC regulations require that investors be notified. Until that time, do not expect 15 minute updates like you would get from a surgical nurse as a family member undergoes a heart operation.
Just relax..............and "watch the blinken' lights!!!"
Wow...that is a tuff one. However, RMTI is expecting to revise guidance with the expectation that shipment will occur in the 3Q 2016. For RMTI that is anywhere between July and September....If you add in another quarter for good measure, I would not expect anything concrete until the end of this year beginning of next year (RMTIs fiscal year coincides with the calendar year).
It looks like it was not the actual active ingredient that was improperly synthesized, but the stability of one of the incipient reagents, or the vehicle used to stabilize the drug (often times appearing on a label as "inactive ingredients") that was the culprit. This is usually purchased from a supplier rather than synthesized by the manufacturer.
So, expect the worst (January or later) and hope for the best (July-September) and you probably won't get disappointed.......again.
I assume (and it is merely an assumption on my part) that RMTI pays the manufacturer only for a finished, delivered product. If there was no accountability on behalf of the manufacturer, we would all be in big trouble regardless of the product. A good example is the mess that has been ongoing for two years now regarding faulty airbag relays in most cars on the road. The Auto manufacturers are ultimately accountable to the customer; however, the cost of the new relays and probably the cost for retrofitting are squarely on the producer of the faulty relays. That being said, all investors suffer because the industry gets a black eye and the auto stocks tumble.
Don't be surprised if within a day or so you see more lawsuits crop up as if this was the fault of RMTI.
As noted above, if memory serves, the entire reason for the delayed launch in the first place was a change in manufacturers which prior to manufacturing had to be approved by the FDA on paper and physically. Now we find that all the whoopla over that change has garnered us more anguish.
In the end, it should cost RMTI little out of pocket directly; however, if they contractually promised end users or sellers specific dates on shipments, RMTI could get sued over missing those dates, which in turn they will (should) pass onto the manufacturer.
Now, here is a wrinkle that could be interesting....if RMTI contracted with the raw material suppliers themselves to have the precursors sent to the manufacturer....all bets are off. The manufacturer then argues, "we did not buy the raw materials, you did".
Perception is everything and right now, regardless of who is at fault, RMTI ends up with the black eye.
First...full disclosure, I was in RMTI for a long time and sold at $14 and been looking to get back in...
I understand your frustration. But even if management has been holding onto this information (which would be a violation of SEC rules), the only difference is that yesterday's announcement and concomitant response in stock price would have happened earlier. You still would have had no advanced warning and no chance to sell. So this is a moot point.
Can one blame management, I guess so. I for one have no idea of the timelines on these events, but management always becomes the best target for investors. That does not mean management is to blame in this particular incident. Case in point, you take your car in for repair; it needs a new part. At the end of the day, you pick-up your car and you find it has the same problem...nothing has changed. You are furious and blame the repair facility. The repair facility takes your car apart and finds that the brand new part they just installed was defective. You can blame the repair company because they repaired the car. They are responsible, but they are not at fault.; they had no way of knowing that a brand new part, right out of the box, would be defective. RMTI signed agreements with and assumed that the manufacturer of Calcitriol knew what they were doing and would produce a quality product....the manufacturer failed.
Can you blame RMTI management for choosing that particular manufacturing facility and not meeting quality controls? I guess so, but how was RMTI to know? If they chose another facility that would increase the price by 50% that would have #$%$ you off as well. Remember, the choice of manufacturing facility is a key metric that postponed the launch two years ago and we never really knew why. Agreed, there is much going on right now, but hold judgment until all the facts are presented.
First, you cite a lot of numbers but in the end fail to see that Auryxia is not generating the interest we had all hoped it would. How do you reconcile that the so-called "nuke" drugs for Hep C target a patient population of nearly 150 million and with less competition for successful medications than those targeting hyperphosphatemia? There are risks in everything I understand, but the risk/reward for this type of drug can simply not be compared to Auryxia.
Second, you are also correct that Idenix had virtually no revenues when it was purchased by Merck; however, Merck was not purchasing Idenix for their revenues. The drug in question had not yet been approved or marketed, so this is a non-starter. Merck knows the market potential of such a drug and was willing to take the risk. So this situation cannot be used to support an argument that Merck was better able to market the drug than was Idenix. Merck had/has plans to generate a combination treatment that if successful will cure nearly all Hep C patients in less than 2 months....huge difference.
Third, whether or not K can be valued at $2.5 bil does not in and of itself generate corporate interest. The two are simply not mutually exclusive.
Finally, Cerna, we may have to agree to disagree at this point because although Auryxia will do well and take its share of the market, it is my contention that it will not generate sufficient interest for a company buyout. I understand that point of view contrasts with the ultra positives on this board, but that is how I see it. I stand to benefit substantially if I am wrong...but I don't think I am wrong.
interesting maybe, but certainly not comparable. This is all based upon a new type of Hepatitis C drug to treat a disease that affects nearly 150 million people worldwide; a far cry from the patient population targeted by Auryxia ( 3-4 million). Also, Gilead Sciences Inc. acquired Sovaldi through its 2012 purchase of Pharmasset Inc. which is one of these "nuke" class of drugs for treating hepatitis C. Gillead generated nearly $2.3 billion (with a "b") in first-quarter sales of Sovaldi...another far cry from Auryxia. They charge $85K for a complete treatment...a third cry from Auryxia.
I don't mind comparisons, but lets keep them real.
Thanks for the clarification. I suspected as much, but I think that many on this board cannot or do not delineate between a treatment facility and medical directives. They assume that just because a patient is being treated at a dialysis center, that center is now in total control of the patients medical care. I am sure that this may occur to some small extent with regard to addressing immediate problems, but from a holistic perspective, dialysis centers do not dictate treatment. This is in the hands of the nephrologist/physician. Further, if physicians gravitate toward better treatments, it makes sense for a dialysis clinic to similarly gravitate or stand the risk of loosing referring physicians and therefore patients.
I have a question for you that seems to have been bantered on this site quite a bit...at least on the last couple threads. Quite frankly, how much influence does a dialysis center have on the modality of treatment? Namely, some have indicated that FMC will not permit infiltration of products from Keryx into their facilities. I have always maintained that the nephrologist is the one who writes orders/prescriptions not the dialysis centers. I understand that there may be some posturing ongoing at times but in the end, the nephrologist ( attending physician) is in control. Can you clarify/elaborate?
I know. It is kinda ridiculous that we continue to read the number of scripts per week and some seem to get so excited that it went up by "20" scripts. In the end, it is all smoke and mirrors. It all comes to the quarterly report and earnings. Further, I really do not think that anyone has any idea how many scripts are generated. Every time someone presents the information we get those who follow with "...but those do not include this... and those do not include that.... and how many of these are reissues...yadda, yadda, yadda."
And you are correct, Auryxia should be able to garner 10% of the market. That is indeed a reasonable estimate. But given the flux and competitiveness in this industry and the development of even newer treatments, I simply do not think that this engenders a $19-48 price target.
A_gas prognosticates a 5 1/2 month limit on his a company sale. I guess we will wait and see.
OTC iron works in approximately 50% of the cases. Keryx based its recent P3 trial on a sub-population of those in which it did not work. Among that sub-population, Auryxia worked in 48% of patients.
Nope. Tahloolaa, I don't have a damn thing figured out. The only things I know are............1) no one else does either; and 2) when investing in stocks it is more prudent to be realistic than optimistic.