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Full disclosure: I own as many NWBO long shares as I can afford, yet I am also short.
Thank you Vator.
Are direct shares preferred shares or some other class than common?
The president of IMUC quietly bailed out in the weeks before the bad news and nobody on message boards talked about it. Not saying this happened here... need to look at more SEC docs I suppose to be sure. If LP retained warrants or net moved things to warrants, then there is still good reason for hope. Even if she just flat out bailed, you are right that there is some hope, but scary situation.
Re: LP Holdings Vanilla Header not trying to make a stink but want to ask this to a believer and don't have messaging privileges: Why does the NAS say that LP sold the last of her shares in late 2018? Is this misleading or is there a common view/explanation here among longs? I know the NAS numbers for pink sheet stocks are often not accurate, but thought I would ask about this.
https://www.nasdaq.com/market-activity/stocks/nwbo/insider-activity
"DCVAX(R)-L", "DCVAX(R)-Direct". (R)?
Is any of that increase conversion of warrants?
What I meant to say is; if DCVax-L proves successful; at this point, I think you would have to give as much or more credit to Linda Powers as to Lynda Lau.
The title of the Slide is "Updated Unblinded DCVax-L Data" ...equivalent. And the date below says 2019. But as we all now know it was not updated data, but data from 2018. In fact, it was the same data presented at last year's SNO conference and possibly the same slide with the date on the bottom added.
I do not believe for a minute that was an accident. The only question is whether NWBIO intended for that image to be broadcast or just the person tweeting. Not an issue for the presentation probably where the fact that it is 1 year old+ data was probably explained, just an issue to tweet that deceptive image with no explanation that in fact it is year old data.
I remain hopeful that DCVax-L for GBM will prove out, and even more hopeful that DCVax-Direct + CI's will prove synergistic.
As for deceptive tweets; Since you rub shoulders with these big dogs, maybe you can find out for sure who posted that deceptive tweet and give them some grief. That is not ok.
Did they tell you to "Stay Tuned!"? Just asking, because that would be a sure sign that Top Line data is about to be released any day now.
Also... wondering, are you the one who posted that criminally deceptive tweet that showed a poster announcing "New Unblinded Data" for DCVax-L GBM with a 2019 date at the bottom? Just asking because the guys at the SEC may want to know.
I'm not saying this was presented this weekend. But if anything was presented, this was likely it. That tweet showing that poster was totally misleading, and that was almost certainly deliberate. Tweeter be damned.
Yes we have seen the poster title before: https://nwbio.com/updated-interim-data-from-phase-3-trial-of-dcvax-l-for-glioblastoma/
Impossible SAP-->ITT Stats?
Isn't the SAP here a bear due to the crossover? Maybe worse than a bear? Wouldn't that leave the ITT population to fall back on? If so, they may know exactly where they are.
Only true if no webcast. There is a webcast, so there can be news during the presentation.
I watched the takeover of Therasense by Abbot. Abbot first sent down a mid-level+ manager who got things in order, for about year, prior to acquisition. So while Duffy was not super senior at Merck, his level is consistent with the one takeover that I have witnessed up close.
Of course that doesn't mean that is what is going on here. Maybe iclight is right about the salary bump... but he is making a big assumption with no data.
I have to take the blame for this flurry of negativity. I overstated, out of ignorance, Duffy's former rank at Merck. Exwannabe was correcting me, which was the right thing to do, so as to not lead-on investors.
Not as important as I implied but more important than you make it sound. I stand corrected. He was not the head of the Ketruda program, but he was the head of an important part of it. He is a heavy hitter for sure and his presence is a very big deal for NW and some or all of it's programs.
You are correct Maverick,
Commenting on the reason behind the spike, not the spike itself. And of course the suitablily of Moly as a lubricant for your vehicles. Not sure if it is used during Alien probing, but hopefully that question will prove moot.
Holy$#&n Moly!
PDT and PST are the same thing as far as I know.
2:15 PDT. 2 hours difference not 3. https://savvytime.com/converter/cdt-to-pdt
Thank you Flipper: Just got off work. Will have to study this for a while.
Anyone: Datalock PR? When was that PR? I can't find it? The way I remember it, LP announced that they felt the trial had matured to the point that datalock was appropriate. She went on to say that it could take a very long time to finish the locking and then collecting and analyzing the data.
(As I recall) Flipper (traditionally one of the most if not the most positive honest person on the board) had recently felt burned by NWBIO on-goings and was critical of the claim that they would need a long time for data analysis, saying that the plan and algorithms would all have been in place long ago... Or am I hallucinating again? FMS False memory syndrome?
I hate being so wrong, but I was feeling guilty not saying anything. Of course I am net glad that I was wrong. The 100M preferred (approx 1B common equivalent as far as I know) was just shares authorized. As for what is outstanding for preferred, I don't understand the doc, but it is certainly a tiny fraction of the 100M. Not that such could not change overnight, as far as I know and based on a bad experience at an employer 30 years ago.
I still don't understand why the forced conversion of all outstanding preferred to common does not show in the 10Q, but it is not a huge issue.
Again, my apologies. I had been worried about it for months now and hadn't said anything. Thanks for ignoring me. Less bad karma that way.
I will be surprised if the OS estimate that you make is not surpassed (nearly) 3 fold as per the next 10Q that should include the count of preferred shares forced to common since the last 10Q.
I hope I am wrong. I have a hard time understanding the regulatory docs and I'm not sure if the number of preferred shares involved was listed as the common share equivalent or not. If so, then the dilution would only be about 100M shares common, and your estimate would be right. But my guess is that there will show a 1B share dilution to 1.51B or something like that.
I am still very hopeful for DCVax-L and Direct both, with CI's if not without. (Particularly hopeful for Direct with CI's which I think could be the marriage of the century).
I don't think this is what they meant, but the company, in their recent PR about the meeting said, "In controlled clinical trials, oliceridine demonstrated efficacy compared to placebo".
Tell me this is not what they meant. Please.
…. Oh... I read this as "efficacy comparable to placebo". compared to is better.
Patent: The way I remember it, Anavex was arguing that there was synergy shown for 2-73 with a very small amount of DZP or similar added. This very small level of dosing probably made any competition for the Sigma 1 Receptor a non issue. It would also make the cost of adding that very small dose of (now generic) DZP (or similar) a non-issue.
That was the final standoff... Anavex claiming this synergy at a very small dose of DZP... and then the patent was finally granted.
I think you will find this history in the "Image Wrapper File" or other records. https://portal.uspto.gov/pair/PublicPair
Significance of "Precision Medicine" is understated. In this proposed trial the advantage to the 20% of patients that will be left out is not just the ability to try other treatments. Being left out opens a market and thus an incentive, and thus cash for development of new treatments for that 20%. That is why this type of patient screening is not just smarter, but more ethical.
So how good are those scores? 80% is an enormous subgroup to go after, much larger than I thought they would go after, but how much improvement is what he is describing, and are those two measures enough to convince the FDA?
Either this is fantastic news and the big dark ominous powers are trying to keep AVXL sp down, or these results aren't significant. Is the quote not what it appears, or the man quoted not who they have painted him to be?
HTF can the sp be dropping if that quote is accurate and the guy quoted is who they say he is? Maybe really is Overstock.com syndrome (big evil dark forces manipulating share price).
Or maybe they are getting the funding out of the way early to allow for an uninterrupted stairway to heaven in the near future.
Not sure about skyrocketing, but I am anxious to hear what they have come up with for patient screening. They have not talked hard numbers in the past from my recollection. History says they will avoid it again, but I am hopeful. Alzheimer's is so huge that any significant subgroup is also huge. Further, not only does targeting improve their chances of success, it is the more ethical approach. It is just better, if it is not a random curve fit as some have warned.
PR legalities if data lock has been reached? I haven't been following the board lately. I am sure the subject has been discussed. Very interested in hearing the various views on this topic.
It would appear to me that they have now reached official trial maturity / data-lock / un-blinding / the primary endpoint. Of course that is not a certainty but the smell of such is all over the place.
If so... what are their PR legal responsibilities as a public company? I know they can't say wrong things... and maybe that means they can't say anything until they understand the data? Given the primary measure of efficacy was to be progression, and progression is a little debatable (though whether it is debatable is debatable) maybe they have to examine the data for quite a while to be sure what to say about progression, even if ignoring subgroups. Regarding survival, however, it would seem they would have to have a PR very soon, unless it being secondary puts it so far in the background that these laws don't apply. They could always give the survival results, even if bad, and say that subgroups are being analyzed to appease Matthew McConaughey, flipper, sentiment, cherry tree, etc.. and myself.
Not sure about tomorrow, but I do believe things are finally happening.
I decided not to post it because I don't want to give the publication the attention. Apparently it's his own publication at his own website.
I should correct my post. Adam isn't saying that Spain left the European Union, he is saying they left Europe. Apparently just got up and moved overnight. No reports yet on where they moved the country to. But I took the leap to assume they had to leave the EU if the left E.
If anyone has sighted Spain, please tell us about it.
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"ADAM'S TAKE
Red flags fly over Anavex: What’s stopping the drug maker from enrolling U.S., European patients in trials?
By ADAM FEUERSTEIN @adamfeuerstein JULY 9, 2018
Anavex Life Sciences, a small drug maker in New York City, has committed publicly to an ambitious roster of clinical trials for its lead pipeline product Anavex 2-73, including trials in Alzheimer’s, Parkinson’s, and other serious neurological diseases.
But does Anavex have clearance from regulators in the U.S. and Europe to enroll patients in those Anavex trials?..."
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Adam Feuerstein announces Spaxit, Spains overnight exit from the EU. In a shocking news article that will undoubtedly rock the world markets tomorrow, Adam Feuerstein claims to have exclusive inside information that Spain is no longer a member of the EU where data leading to drug approval in one member country can be used to support drug approval for all members.
At least Britain had the courtesy to announce their plans well in advance, while Spain apparently chose to wait until hours before their exit, and then tell only one man, Adam Feuerstein. Why Adam Feuerstein? Well Adam, often affectionately referred to as "Kramerstein's Monster" is a world renound expert on everything from beer to baseball to Brain Cancer to Parkinson disease, just ask him... all with only a BA in political science. A truly uniquely talented man; one of few at Martin Shkreli's level.
No $2.62 in the 8K. Not even in the complete submission text file. Where did you get that?
Re. enrollment. 2-73 had a big fan in that MD in charge of the clinic where they ran their studies. If he is still a fan, I would think he would be great help in speeding enrollment. As I recall, he was the top Psychiatrist in Australia for Alzheimer's. I don't remember reading in the PR whether they are going to only enroll genetic and otherwise identified suspected super-responders, but if so, that, of course would make enrollment more difficult. But again, they likely have the heaviest hitter in Australia assisting them in finding patients and talking clinics into participating.
US P3? Might want a partner. Could it be Biogen? As a cheerleader and long investor I believe it could be.
Makes total sense to do a study in Australia whether or not they do one in the US. And the study in Australia would be easier to setup and get approved, so would be announced first.
Doc Logic: There was much more wrong with my post. I could feel Pryo's face contort when I later realized how off I was. I was talking as if they were injecting the tumor proteins / lysate rather than the loaded DC's. I guess I'm rusty. Wish I could say I was drunk... but not the case. If anything like my worries does happen, it would be like this: Excess DC's (if any / as one person claimed) die and macrophages bloom/converge locally to eat them up. The macrophages would provoke inflammation response in the surrounding tissue... including raising the blockade flags. But this would likely just be local to the injection, not up in the brain. So... no way to rationalize my being that full of it. My bad. (I used to hate that saying but now that it is 20 years old I like it.)
To balance years in the past talking positively about DCVax-L, I need to point out a few things that most, but maybe not all of you already know.
You are now hoping that the DCVax-L applied to GBM is much more effective than other DC therapies applied to other indications.
Although I remain somewhat optimistic that NWBIO has reason to be optimistic, I have to point out two things that weigh on me.
1) ARGS recently announced final failure of their DC therapy. About a year ago they announced failure, then came back to life later saying that they saw a tail in the data, so wanted to give the tail a little more time to grow. Based on their relatively recent PR pasted below, I believe they collected another year's worth of data, and in the end concluded that their DC therapy did more harm than good. That announcement about a tail forming made me feel good about DCVax-L with the view that NWBIO was being wise to let that tail form before data lock, unlike ARGS. But ARG's final result is worrisome.
2) I was very loud with my criticism of AF when he touted the single bullet approach over the shotgun approach (just before Celdex's limpit extract failed). His analogy, as presented, was ridiculous, however, in retrospect, the DCVax-L shot-gun pellets are predominantly self-antigens, not neo-antigens. That huge excess of self-antigens likely has no good effect, however, it may have a bad effect. Those self-antigens do not excite any T-Cells, but do they excite anything else in the immune system? Do they create any elevation of the immune system that might provoke a defensive response with tumor cells responding by raising checkpoint flags, as other cells would do? Almost certainly 30 neo-antigens is better than just one neo-antigen, but what about one neo-antigen vs (30 neo-antigens + 10,000 self-antigens)? I don't know.
It is in everyone's interest for the DCVax-L trial to finish. I still applaud and admire those that have done what retail individuals can do to keep the company afloat long enough to get to that point. At this point, assuming the trial really is about to finish, negativity may be a rotten thing, so, I will not be repeating my concerns. In fact I might still buy shares if I dig out of my unrelated financial mess in time.
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DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial.
As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.
The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.
Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.
Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.
Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company's common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB® Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos is developing an Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
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I don't see LPCN 1111 nor 1107 at clinicaltrials.gov. I have searched in every way I can think of and see absolutely nothing regarding phase 1 nor phase 2 for these drugs. One is a once-daily oral T, and the other is an oral T for prevention of preterm births.
I have recently submitted a request for clarification from the company, and I am awaiting a reply. If I get a meaninfull response, I will post it.
If someone finds any trace of a study for either of these drugs then please reply to this post with a link to that evidence. Don't bother to post the companies claims that they have done these studies and negotiated with the FDA, I am looking to solve a very important mystery and such claims are not of use in that effort.
I don't dislike the company, but I cannot invest until I find out why these alleged studies are not showing on clinicaltrials.gov..
By the way, I posted a similar question on the yhoo site and it was soon deleted.