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"Dr. Buzdar has no associations or financial interest with this company or any other pharmaceutical company. Nor does he serve as a consultant or scientific advisor for any company."
When we looked into this we found this statement was very misleading. MD Anderson had a standing contract with Glaxo-Smith-Kline for royalties for a competing product. It is a huge contract. Given that Dr. Budzar works at MD Anderson, he benifits from that competing contract. Therefore this statement by MD Anderson was simply false.
Further research showed that both GSK and MD Anderson had soiled their reputations in the recent past due to misconduct. GSK had recently paid a record fine for misconduct in their marketing practices, and MD Anderson had also been censured over a related issue... I don't immediately recall the details of that censure.
My source regarding the Agenus efficacy must have been primarily their most recent webcast from the 26th Annual Oppenheimer Healthcare Conference. Starting from 14:30 they talk about the new trial for Prophage for GBM in planning.
What they say is a little different from what I remembered. They say the efficacy that they have seen allows them to move to a potential registration trial without changes for half of the patients. They say for the other half they want to add a checkpoint modulator.
They don't say explicity that they are basing this on the results of the phase 2. They don't say explicitly that the two patient group (halves) coincide with Temador response. And they don't say explicitly that they are talking about a phase 3 trial. Maybe it is a phase 2/3 trial... . They just say it will be a potential registration trial and likely take 2 years.
They don't give efficacy numbers in the webcast. Sounds like we will hear numbers soon. Perhaps they will also clarify what the characteristics are for the half of patients that did not respond well. In the webcast they only say that they think they can identify those patients apriori.
I am not currently invested in Agenus in spite of their many interesting programs. As far as I know they do not have anything imminent in the pipeline, which for me is a requirement.
As I said back in post #48092, I was talking about Celldex's ACT-Whatever trial for newly diagnosed GBM.
You were apparently talking about their trial for recurrent GBM when you compared their relative ease in recruiting patients to NW's difficulties for DCVax-L. Not sure why you would use that trial as a comparison when a better Celldex comparison exists.
I am certain that Cramer failed to mention the EGFRvIII positive restriction in many of his verbal statements about efficacy for newly diagnosed GBM. In that era, you and Cramer both hammered NWBO often, and made comparisons to Celldex. That is where the comparisons originated. That put me and others on the defensive, and when, in response, I scrutinized the Celldex data presenation, I found it was clearly deceptive... for the newly diagnosed GBM trial. I don't know if they used the same deception for the recurrent GBM trial data.
I can't find the report that I am recalling. What I thought I read recently was that Agenus did report Phase 2 results for Prophage and plans for phase 3. What I thought I read was that results were good, but only for the patients that respond to Temador, which was about half the patients, so their plan was to utilize a blockade inhibitor with the other half of patients.
I will keep looking for the report.
Whatever that report was, it appeared to tank DMPI, and I assumed the reason was that "DMPI's" chemo was not chosen for the Temador non-responders.
""Where did you get this info concerning CLDX and their p3 Rintega trial?"
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Feuerstein was making a comparison between a Celldex trial and the DCVax-L trial. As far as I know, the corresponding trial is this one:
"ACT IV— a Phase 3 Study of Rindopepimut in Patients with Newly Diagnosed EGFRvIII-Positive Glioblastoma"
This is the trial I was talking about. If that is the wrong trial, then my apologies.
To understand why I would make these claims for the ACT IV trial, please see post # 48136.
I missed Feuerstein's reply. Maybe that was for the best.
Why then has Agenus reported substantial efficacy in their GBM trial. They too are using a shot-gun.
"It is most certainly not the case that CLDX only enrolled patients after they showed a response to the treatment. That would be completely useless for a randomized trial."
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I based what I said on my recollection of Celldex's published descriptions of the trial on their company website about 18 months ago. To me, it was very misleading the way it was presented because the efficacy percentages were really for the small number of patients that had the right genetics and were let into the trial, but that was obscured in their text, and in the statements I heard made by Cramer as he praised the results thus far.
Currently, the Celldex web-site states:
"ACT IV is a 2-arm, randomized, Phase 3 study investigating the efficacy and safety of the addition of rindopepimut to the current standard of care, temozolomide, in patients with recently diagnosed EGFRvIII-positive glioblastoma"
http://www.celldex.com/clinical-trials/brain-cancer-clinical-trials.php
What I read in the past was that their method of determining whether the patients were EGFRvIII-positive was injecting the patients and looking at the subsequent changes to titers. Maybe I am wrong about what they were injecting, but they were injecting them and looking at the resulting immune response. That was part of the screening before enrollment. They didn't do DNA analysis, for instance, to see if the patients were EGFRvIII-positive.
So, what were they injecting as part of screening?
What data is due?
"Celldex enrolled almost 750 GBM patients into the ACT-IV study in three years."
Screened patients were injected, and only enrolled if they showed a sufficient response to the treatment. So the number of patients that were screened was much larger than 750. Most were turned away. Those turned away were likely no longer elligible for other trials, in part because they had already been treated, and in part because it was too late.
Again, Celldex worded their statements about efficacy in a very clever manner, greatly exaggerating the true percentage of patients that were helped by the treatment. If they used the same deceptive language in presenting the option to patients, then they conned a large number of patients out of other therapy options, and you and Cramer helped them with that con by pumping Celldex continously, never mentioning this deceptive description of efficacy, and constantly hammering DCVax-L.
"If you want to get picky, enrollment into the ph3 study has been sloooooow and delayed, even before they added patients and stopped screening for new patients.
That just shows you how little demand there is for DCVax. No one cares about it.
Ten years to enroll 348 patients. Pathetic.
Celldex enrolled almost 750 GBM patients into the ACT-IV study in three years."
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As I recall, a very small percentage of patients respond to the Celldex drug. A much smaller percentage than appear to be responding to the autologous DC therapies.
Celldex hid this pretty well in their website write-ups on efficacy, and neither you nor Cramer pointed it out. I wonder if Celldex hid that fact from all those patients that entered their trials.
Maybe patients and physicians were not impressed with DCVax-L data... or maybe Northwest didn't have as good marketing. Or maybe Celldex didn't have a professional hit man hammering them continously, possibly effecting patient and physician opinion. The same hit man that didn't say a word about the tiny percentage of patients that the Celldex product is effective for.
Or maybe Northwest was just too broke to build the trial very fast. The same hit man that may have kept patients away kept SP down, making it more difficult to fund the trials.
In the end, if you are right that DCVax-L proves to be ineffective and or Linda Powers proves to be a crook... then much will be forgiven. But even in that case, your methods are not ok, because the fact is, you don't know for certain that DCVax-L is ineffective, nor that LP is a crook. All you really know is that the autologous therapies are more expensive than the complement.
And if DCVax-L proves out to be a good solution and manufacturable at a reasonable price, then you will have screwed hundreds or thousands of GBM and other patients by slowing the trial.
First interim models? Any day now? 70 events or 76 since trial over-enrolled? Any reason to expect feedback beyond go / no-go?
I like Portland, or rather, the few people I have met from Portland. Not sure that is sufficient DD. But... they were very smart as well as nice. So... getting out my wallet...
I agree. I don't want to cheerlead, but the website being down for 2 days does suggest it could be under reconstruction due to big changes that we have been waiting for.
The PR today could have been a plan B PR for if the website was not up in time. In time being this morning... a Monday morning. The Monday morning before Christmas.
I believe this interview with Cramer was soon after he was fired by his own Hedge fund. Clearly he was getting even with them by telling on them... actually telling on himself. It was not the brightest move in Cramer's career.
A key point; in the video Cramer talks about the need to have access to the highly visible personalities at CNBC in order to accomplish this illegal manipulation.
As I recall, after the resulting investigation of Cramer by the SEC was suddenly shut-down by the head of the SEC, without explanation, Cramer was given his daily show on CNBC. UFB!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Note that Cramer's clients at his former hedge fund included not only the super rich, but the super powerful, such as Eliot Spitzer.
Better link to $2.6B estimated cost to get a drug to market.
http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study
The link I provided earlier was a critique of this estimate by that author at Fierce Biotech. Oops.
The author's primary criticism / correction would reduce the typical cost to $1.4B. Even if he is right, at $611M, including work on Direct, $NWBO has spent less than half the typical to get a drug to market.
Mr. Feuerstein,
You want us to believe that you are out to protect us from shady dealings that rob retail investors. Yet I never heard a word from you when AEZS and other companies recenty unleashed death spirals that handed 90% of retail share value over to the institutional investors. Not one word.
To me, that is strong evidence that your role is by no means as a protector of retail. To the contrary.
Recent results from IMUC and AGEN are very similar. The numbers may not be huge, but as I recall, the results are statistically significant.
As I recall, what both studies showed was that there is a large-enough improvement in OS when DC therapies are used along with Temador, for patients that respond to Temador.
For IMUC the response was only good for patients in their limited genetic target range, while for AGEN, which uses an autologous technique, the response was good for literally all patients that respond to Temador.
Unless there are problems unique to Northwest's procedures, there is no reason to think that Northwest will not show significant improvement in both PFS and OS for patients that respond to Temador. According to Agenus, that is about half the patients. $NWBO NPV $2.5B if they are approved for only the patients that respond to Temador, according to a popular, published, independant estimate (of $5B if approved for all patients).
The 10Q for September 30, 2015 lists $611 million as the "accumulated deficit" for Northwest. That is less than I thought.
http://www.sec.gov/Archives/edgar/data/1072379/000114420415063856/v423331_10q.htm
This recent New York Times article claims that the typical cost to put a drug to market is $2.6B. If Northwest is nearly done with getting DCVax-L to market then where's the beef?
http://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html?_r=0
"It would be appropriate if the majority of $ that shareholders have forked over, over the years, have ended up at Cognate."
Let me be a little more clear. It would be appropriate if the majority of the $ that shareholders have forked-up, over the years, have gone to or through Cognate.
Cognate handles setting up new clinics, including training. Again, they do just about everything for Northwest. For the clinics, and many other functions, much of the money that goes to Cognate actually goes through Cognate. At least, that was my impression.
What about the big Real Estate expenditures? Did Northwest pay that directly, or did that also go through Cognate (not to Cognate)?
To get approval in the US or Europe, Northwest needs to make regulators feel confident that they could handle the manufacturing burden that would result from approval. To that end, buying that real-estate was necessary before or while approval is being considered.
I admit, however that I am not scrutinizing these things, and that is risky.
""Disbursements" equals cash in Linda Powers' pocket."
This article in the New York times states that it takes about $2.6B to get a drug to market.
http://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html?_r=0
What is Northwests total accumulated shareholder liability? I can't find it quickly. My vague recollection is that the total is about $1B, or less than half the typical cost (according to that recent article).
I would argue that if the total accumulated shareholder liability is smaller than typical then it is not reasonable to damn the company for expenditures. Nobody is happy with the lack of visibility, but they know that Cognate does a great deal for the company. That is why Northwest can get by with so few employees. It would be appropriate if the majority of $ that shareholders have forked over, over the years, have ended up at Cognate.
A special, independant investigator is appropriate given the lack of visibility that has been maintained for years. But they have one. We will just have to see. Whoever wrote that Phase V article better not have synthesized those accusations. The era of being able to do that under the umbrella of the first ammendment may be coming to an end.
Your right. Even if they did half the patients this last year it would not be close.
Obvious to combine 2 drugs of similar action?
No!!!!!!!!!!!!
One needs to start with the valid assumption that each drug has found an optimum dose, and going to a higher dose for each generates excessive side effects.
Say that Drug 1 is optimum at dose A, and Drug 2 is optimum at dose B.
Then it does not follow logically that one could gain any advantage by giving the patient Drug 1 at Dose A and Drug 2 at Dose B, because logic predicts that such a dosing would create excessive side effects.
At the same time, simple logic predicts that administering Drug 1 at dose A/2, and Drug 2 at Dose B/2 might allow acceptible side effects, but would likely result in a level of efficacy no higher than either drug alone at their respective max dosages.
What would not be expected from simple logic is that one could find a dosing combination of the two drugs that does not generate excessive side effects, but does generate significantly higher efficacy than either drug alone. Such a result would be synergy, and such synergy is not expected based on simple logic, thus it is not obvious.
I see where porgyrusty was coming from, but I agree with your response, and I would add;
Warrants are TPIV's bread and butter right now. They have to want warrants to be exercised during the large volume following good news. That is survival.
Right now, I wonder how much true volume there is. The M&M's create volume out of nothing, but if you could subtract that, how much real volume is there right now beyond tt et al moving over to av and back on patent + then - news? Probably not much volume right now due to caution over the fed rates decision later today.
So... if trading is really frozen right now due to fed caution... it would be dumb for them to PR a partnership prior to today, or tomorrow, or whenever things get back to normal.
All in hind-site. I bought late at $.89 because I was out chasing another stock's catalyst/response. One that did not materialize in the pre-fed-rates cold environment. TPIV is doing this right.
I hope they stick to their plan to PR the Ph2/partnership in question this year, and I think they will, soon.
Azacitidine is now Generic! That is an even better situation than I thought. That means Celegene is not the only potential partner or buyer.
I'm relatively new. For people even newer, MEIP's Pracinostat was tested along with Celgene's Vidaza (Azacitidine).
But I hope MEIP waits 6 months to talk turkey. By that time they may have finally reached median OS for AML, and will have better proved out the rest of the pipeline, greatly increasing the NPV of the company. And by that time they will have a pack of dogs fighting over the dog-food bowl.
Results posted on MEIP website: Median OS not reached yet but 14.3 months so far. They will be doing a Phase 3 for AML.
"These are impressive results by virtually any measure for a group of patients in dire need of effective new treatment options," said Dr. Garcia-Manero. "Not only did we observe a high rate of responses, but many occurred rapidly and continued to improve with ongoing therapy. Most importantly, we are seeing an encouraging trend in overall survival, particularly among patients who achieved a complete response. These data clearly support further development of Pracinostat in combination with azacitidine for the treatment of elderly patients with AML."
http://investor.meipharma.com/2015-12-07-MEI-Pharma-Announces-Positive-Results-from-Phase-II-Study-of-Pracinostat-in-Acute-Myeloid-Leukemia-Plans-to-Initiate-Phase-III-Registration-Study
Anybody know what the fully diluted OS is? I am using 36.66M shares, but I am not sure what it really is. They stated it during the last webcast... I will check that, but if you guys talk about it all the time, I would like to compare to what the company says in the webcast.
The data from August, reprinted in the recent SA article, page 3...
http://seekingalpha.com/article/3642996-mei-pharma-should-be-bought-ahead-of-ash-conference
That data just points to a buyout possibility, in my opionion. Just stare at that data for a while and I think you might agree.
Nothing I have heard... but since it really looks that way to me, and I bought in because of it, I don't mind putting the idea in other people's minds.
I worry a little too. I do understand that people, including JBEM, felt a little burned by the last data release. I suppose there could be a negative surprise, but not sure how. Median OS has to be pretty good at this point if that SA Article was accurate. My only concern is whether they can update the CR number in a bad way. I wouldn't think they could change it after trial end date... but maybe if they are still having to watch for the median OS... maybe they also update CR? I don't think so, but a small concern. Of course CR could go up.
There can always be tricks with the stock itself... but so far nothing. I don't consider the recent employee benefit / dilution a big deal. I hope it is them patting themselves on the back for a job well done, and possibly, positioning themselves for aquisition... or partnering for phase 3 with associated SP rise and liquidity.
But I have no inside info, nor anything beyond the recent PR's and reports.
"... we expect MEIP shares to rebound."
From your own post. Obviously you are here for manipulation. You likely work for Celgene (who will be buying MEIP shortly for about $1B but is hoping to get away with only $300M using people like you to stand off retail)?
"Should the trial show any signs of efficacy in the secondary analyses, we expect MEIP shares to rebound."
Very impressed with Hooper as an SA author. Some of his posts here on ihub have been so technical and detailed that my eyes glaze over... which admittedly happens too easily, particularly in the biochem space. But this SA Article was kept very simple and trimmed down, yet contained key, core technical and financial perspective that even a layman can quickly research to verify or at least augment credibility.
I think Hooper understands his broader audience.
So where can you trade at 6:20AM EST and where did they get the news this morning at that time?
TD Ameritrade premarket starts at 8AM EST as far as I know, and the news on that marketing arrangement this morning didn't reach me until 8:31 AM EST, more than 2 hours after the spike this morning. And that news is still not on the AEZS company website, nor registering on Yahoo Finance.
They just finished the death spiral yesterday! And today they take a dump all over retail in the middle of the trading day!
Isn't there an SEC regulation that says you have to take dumps on shareholders outside of market hours? I believe so.
Must be ok as long as you give a heads up in advance to yesterday's institutional owners of the magic B warrants. That way they can short immediately after the announcement. Retail is fair game. No civil attorney will represent retail. They are too poor.
God I wish we had an SEC. We should form one. First presidential candidate that proposes forming an SEC gets my vote. I don't care which party or gender.
Nice thought... but it would be even nicer if excessive efficacy did not prolong a trial. And hopefully AA is the solution to that dilema, if such a dilema exists.
Good stuff Sentiment. Very good stuff.
Why does the article even mention Northwest Biotherapeutics? The article is written to damage Northwest. That is a certainty.
I am watching similar blatant stuff going on with another stock. The street is pumping this other one up in prepartion for shorting it. They will point to their own pumps and accuse the company of having solicited them when the stock is ripe for shorting. They just got through doing it a couple weeks ago. They are at it again. This unbelieveable. Totally out of control. Unnnnbelieveable!
There is a video of Martin Shkreli eating his boogers circulating on iHub. I would post the link, but I'm not sure how old the video is, etc... . The video does look real.
It's a webcam video. Maybe he accidentally left the webcam on, or maybe somebody hacked it. I honestly don't know anything about such things, but One might assume it happens. You should probably put tape over your's if you are not using it.
But since it could be a hack, and he might be a minor (so hard to tell with him) ... I would recommend not distributing it. In fact, I am going to contact the person that put it on iHub and suggest they consider that issue. But... interesting to see the jerk (Shkreli) making a fool out of himself.
Thank you Sentiment and DoGood. I see why people were excited about the 51 information-arm patients' data, but I see why some look at it cautiously; low number of patients and 5 net-bad patients not included in the stats...
Still chewing on the info... but at least I am up to speed to see what the arguments are about.
If a net net in my opinion, at this point:
If you trust that the selection of the 51 was fair, and further, that NWBO did not get lucky regarding the Methylation status of those patients, then the data looks very good.
I will look back over the reported stats for the information arm. I am now remembering that there was some attempt to break it down into pseudo vs real progressors, with an inderterminate group also. Maybe I would just assume the standard distribution, TMZ works or not, for the indeterminate group...
Wish I were a true iHub member sometimes. That would make searching for such so much easier. (But non-recurring memberships are only short term, and too expensive, and I won't do a recurring membership that does not allow Pay-Pal payment. In Pay-Pal you can shut such recurrence off.).
RK: I've been away for the last year or so, and the board has become much more educated. The arguments have become detailed enough that I shouldn't pretend to be following. So I risk exposing my ignorance here, but;
If the Methylation status for the Information arm is unknown, wouldn't a best guess be that it consists of true fast progressors that do not respond to TMZ, and pseudo-progressors that do respond to TMZ. Clearly other factors involved, or every patient would fall into the Information arm, but the TMZ response being such a strong factor, maybe the best model is to guess that the division is that simple.
I don't remember the number most often used these days for percentage of patients that respond to TMZ. Was it 45%?
What is your best number for % of patients that respond to TMZ, and if you model the information arm as being divided as I suggest, how would you gauge the reported results from that arm?
RK's quotes of ancient LL articles include statements that there will never be an immunotherapy that can deal with a bulk tumor. This statement foreshadows problems with Direct as much as L. However:
1) Linda Lau qualifies this statement as potentially biased because she is, first and foremost, a neurosurgeon.
2) That was before blockade inhibitors. And NWBO is going to be using at least one blockade inhibitor in at least one of the cohorts for the phase 2 trials for Direct. Speculation is that they will partner, and use somebody else's blockade inhibitor. I hope that is not the case, and I worry that no big pharma will want to lend them such for testing. NWBO is not wanting to be bought out. For that reason there is little incentive for a BP to lend them their blockade inhibitor... unless it becomes clear that they can't beat NWBO, so they best join NWBO. Of course there is always the incentive of making money off of the sales of the blockade inhibitor. What I am saying is that incentive would not be as strong as the desire to see NWBO dead, unless they cave in to the eventuality that NWBO is not going away.
I hope NWBO finds an approriate blockade inhibitor or inhibitors for sale, and purchases them. That is more their style, and simplifies the situation. I don't undertand why there can be different formulations for inhibitors of the same blockade type, but there apparently can be. I believe there are multiple versions of PD-1 and PD-L1 inhibitors. I hope there are some left for sale, or some similar that are as promising. Maybe down the road such could be used, at some super low concentration, to enhance DCVax-L as well as DCVax-Direct, if such proves necessary.
A blockade inhibitor may sound like something out of NWBO's price range, but I know of a smaller cap company that recently purchased a couple.
To be very clear. An elevated OS in the control group that uses live DC's unexposed to antigen means that the therapy is not getting a fair test. It means that the DC therapies are better than these tests are indicating. It means some number should be agreed upon for reduction of the efficacy difference bar for approval.
Good evidence of such an elevation of the control group would very likely sway the Europeans, who are capable of non-linear thinking, in my opionion. Not sure it would sway the FDA, but if not, then certainly a topic worthy of public debate.
But that is way ahead... not sure how much of an effect this was on the control group for IMUC, and don't know that NWBO used the same type of placebo. But they probably did, and they are probably seeing the same effect on control group OS. And that issue is probably in debate right now.
But maybe I am not giving the FDA enough credit. There is supposedly a new attitude. Let's hope that is real, and that, "You didn't say "Mother May I"" is not a legitimate argument to fail a clinical trial for a treatment for Brain Cancer.