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AVII: I thought all warrants had been re-adjusted to an exercise price of $1.
Not talking about options here. The idea being that any warrants adjusted to $1 exercise under LP's control would offer a cheap path for her to gain greater share percentage in the event of a takeover attempt in the event of good news.
The third combo partner might be Astra Zeneca with Durvalumab. I think they are more desperate than Merck or BMY. I don't think Durvalumab has been approved for anything yet. They partnered with TPIV, sharing trial costs and each paying for their drugs.
In fact, Durvalumab might make more sense to try than Opdivo or Keytudra because it is Anti-PD-L1 rather than Anti-PD-1.
If I read correctly, PD-L1 is on the tumor while PD-1 is on the T-Cells. Flipper and others have speculated that injecting the BI into, or near the target tumor(s) might greatly reduce the dose required. That would be a big deal. But if so, shouldn't the BI be Anti-PD-L1 and not Anti-PD-1.
Anti-PD-1 would be better for mets, but Anti-PD-L1 would be better for the tumor if applying directly to the tumor allows a drop in dosage.
If the combo of PD-L1 and Direct proves powerful, then there should be a powerful immune response to go with it, since so many neo-antigens and any other antigens that are immunogenic will be brought into the bloom / upward cycle. Such a strong immune response might take care of any mets, so Anti-PD-1 might not be necessary.
Then there is the Russel Rebalance which starts Monday morning. Just want to mention that to offset any undue enthusiasm about the effects of a likely Brexit denial.
Could be more Brexit sigh of relief Monday morning. Could be good news. Could be the start of Russel rebalancing... Could be the Brexit happens on top of that.
I don't know about rotation; that would be nice, but I think you were right about the pending Brexit vote being a big factor. Who knows how long big dogs have been slowly pulling big $ out of pharma stocks with exposure to the EMA. ... and I think the early read is that there will be no Brexit. Maybe today's big gain was early anticipation of price movement to come tomorrow and for a while, or maybe just the tip of the iceberg today if the Brexit gets denied.
Mavericks post yesterday did not actually quote the head of the EMA, but it sort of quoted a restatement of something the head of the EMA said along the lines that a British Exit would result in immediate and complete chaos for the EMA. I don't know when the head of the EMA said that, but I can imagine that $ probably started moving out of the endangered stocks immediately as a result, and are now starting to flow back.
Or (less likely) there is good news around the corner that has leaked. The two are not mutually exclusive. Your speculation that the possible Brexit could be clogging the clinical pipes, or regulatory pipes rather, via budget or other angles, may have been right. There may be some big dogs that believe decisions have been delayed in wait for this vote.
AVII:
How many warrants are outstanding?
How many of those are in direct or indirect control by Linda Powers via Cognate, Toucan, or any other means?
I would gladly pay you the first Tuesday of 2018 for that info/research today.
"Why is SP up 10%?"
I have it narrowed down to 2 of your selections, but with minor changes.
1. in anticipation of favourable Brexit vote, moving with the market.
5. The market wants to prove Turtle wrong.
The Brexit denial was what I had attributed it to, with the assumption that some kind of early read says the Brexit will fail.
But now that you point out the Turtle factor... It could be that the higher powers inferred Turtles prediction of a 50 cent SP as a tell that he has sold his long position and is now short. Once input into the cloud model, this would naturally trip the machine trading to buy buy buy. So, the Brexit issue may not be it at all. So hard to be certain about these things, but I am leaning toward the (anti) Turtle factor.
"In November 2014, the Company approved the issuance of adjustment shares under the most favored nation provision as a result of transactions done with unrelated investors. The approval and the plan to issue the adjustment shares was reported in the Company’s SEC filings at that time and subsequently, but the shares were not actually issued until October 2015, when completion of that issuance was required as a pre-condition of a $30 million financing the Company entered into."
I'm probably missing the point, but if you were Woodford buying $30M worth of shares at a price relating to market value, and knew that an 8M share adjustment (shares to Cognate) was hardwired, wouldn't you want that adjustment to occur before the purchase, rather than after, so that the corresponding price dip would benefit the purchase, which would be fair.
As I read it, it was the timing of the adjustment, not the adjustment itself that Woodford required as part of the deal.
If so, maybe it was just that minor timing detail that generated the NASDAQ violation.
"So what, you think the company couldn't clarify and release a PR saying "we have filed for AA" or whatever? Companies do it all the time. Transparent companies."
I would think companies usually wait until full enrollment to release any such info. NWBO is currently held at near full enrollment.
iclight: Regarding Cash to Cognate 2015: Us hopeful longs attribute much of the big $ spending in the Woodford era to the research and development of automated mfg for DCVax-L. This task was likely overseen by Cognate, but subcontracted by Cognate / farmed out to a large degree.
It is possible that Cognate was running in a profitable mode prior to this automated mfg development era and could afford to receive half of the payments as shares. It is possible that the $ sent to Cognate in 2015 went more to mfg development than to vaccine mfg, without the associated margins, thus requiring full funding from NWBO.
Just debating. Not sure what to think. Once again, the change to cash is consistent with Cognate knowing the SP was about to tank, or with Cognate needing all that cash to hire people to do this very expensive development.
Institutional Ownership as per the NAS website. I don't see a date for it. I read Woodford 25% as you say, but with other institutions combined for only about 16.35%.
I guess I don't know how the Russel works / who buys or sells per Russel inclusion and who doesn't. I would assume Woodford could care less, but how about Credit Suisse? SABBY?
I argued that all things point toward pending success or failure...
If so, then which is more important. That a phase 3 trial for a cancer therapy for GBM with essentially no side effects and early (open label small group) now mature clinical results that suggest strongly that there is very high efficacy for some large subgroup(s) may soon get approved or that it might soon get rejected?
Obviously the chance of approval is of far more significance than the chance of failure, whether you are talking from the investment perspective, the science perspective, the patient perspective, or the ethical perspective.
"What are the current ownership percentages for:
1. NWBO(Includes total of management shares/cognate shares)
2. Mutual Funds
3. Institutions
4. Retail
Will those percentages change again on Monday after official Russell reconstitution this Friday?"
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Another important, well timed post. Thank you for the heads up Flipper. Need to find those numbers and jot them down. Check again down the road... . Will do. Will be educational whether or not pleasant.
And if the institutions gain ground instead of lose ground... then there will be a mystery, and an X-Ray of what the heck is going on with foreshadowing of what is to come. Or not.
"It is not 20-20 hindsight for LP to have known she needed more cash."
You honestly do not know what Sojourner was saying in this? Come on!
"Why would they -(Cognate)- want to be paid in all cash if this thing is going anywhere but down?"
That got to me, assuming you are right about the cash. But it took only a little effort to come up with a pretty reasonable explanation.
Cognate is owed cash. If LP knows anything good, accepting the share equivalent in cash might be insider trading.
It is not clear to me whether LP, as the Pres + CEO of NWBO could buy shares in such a situation, but I'm pretty sure that her involvement in Cognate would prevent Cognate from making any such deal.
Not saying this is the reason for Cognate taking only cash, assuming that is real, just saying that like everything else, there is a possible explanation.
Everything that is going on is consistent with NWBO sitting on very good news, or likely good news, and it is also consistent with NWBO sitting on very bad news, including this issue you brought up about Cognate being paid in cash. Further... what is so strange about being paid in cash?
Further, most think a regulatory decision is imminent. Nobody is arguing that there is certainty of a favorable decision. Cognate likely has many bills to pay, possibly in the immediate term. Maybe they don't want to be paid in Lotto tickets. They already have millions of those Lotto tickets.
Myself I want more Lotto tickets. I would gladly pay you on the first Tuesday of 2018 for all your warrants (at 15 cents each) today!
Great article Maverick. Looks like Flipper was right about the Brexit potentially being a big deal for the pharma world. The head of the EMA had the largest concern of everyone. I'm not going to reprint what he said toward the end of the article but he is not in the camp that says a Brexit would be no big deal in the near term.
The market always gets it right IN THE LONG RUN. Nobody every claimed that the market always gets it right in the short run or there would be no such thing as volatility or a volatility index or trading straddles.
Steppenwolf: Not so. I may be wrong, so I make some effort to not pull in new people, but I am here as an investor because I think the silence may only be about their current legal situation and or about a pending regulatory decision based on a look at efficacy.
It is a certainty that the market doesn't always get it right when it comes to small-cap biotechs. I think Jazz was a recent example sited. These companies flourish or die based on clinical efficacy results, and often, those results are truly unknown to the market until un-blinding. Of course. And of course share price can be manipulated.
The extended silence is absolutely consistent with NWBO knowing it has no hope of approval for L or Direct... but that is not what you are saying. You are saying that is the only possible explanation. That is ridiculous! I think you believe what you are saying, I just think you have deluded yourself.
What if Joe Biden mentioned DCVax-L on Tv after some sort of approval?
Just how outrageously unlikely is that Steppenwolf?
Steppenwolf: So you know for certain that DCVax-L and DCVax-Direct will both fail, or you don't think that issue has any significance regarding future share price?
$30/sh on approval of L sounds about right to me too, but it does depend a lot on how many of the outstanding shares (in addition to issued) are counted in. I will take Sojourner's word for it that about 30M of them is a good estimate. Myself, I would not know what number to use.
Very well written and relatively succinct article Maverick. Thanks!
I am surprised that could come from an author that looks so young (as per pic at the end of the article).
This article does make it sound like budgeting / planning for a major clinical trial and associated issues could be put somewhat on hold while they wait for the Brexit vote.
When you do a play on words what makes it funny is that it makes sense in both meanings.
I am not going to roll in the mud with you. Not worth it.
"Who said anything about 'immediately' or 'straight away'"
You did.
#64943
"a billion dollar company with stock worth $100 a share SHORT-ly"
I should have just ignored you. Sorry. But that number comes across as a pump and that turns some people away. Clearly the stock could recover to something substantially higher than the recent highs if:
1) The Pharma Investment world feels confident that no massive changes are in store for drug pricing policy as a result of upcoming elections.
2) NWBO/LP is substantively cleared of business improprieties.
3) Substantial efficacy is observed for DCVax-L.
4) The Phase 2 combo/partner trials are initiated for Direct with substantial financing from the partners... probably paying half of trial costs. This may not be necessary for SP recovery but it might be depending on L sales and profit projections, etc..
5) A combo/partner trial for L would be great. Not sure how SP effect would compare to the same for Direct. Depends on estimated pricing and volume capability for L. Both pricing and volume capacity is greater for Direct.
But I think all that puts them at max $25 to $50 / share. I think efficacy demonstrated for Direct or Direct/Combo puts them into a larger league reaching or exceeding your $100 figure, but not "Shortly".
Not sure what word that was, but the question is, what OS are you using?
There are 100K shares issued and about the same outstanding. So you are off by a factor of 4 at the full NPV for GBM. If full approval were gained for L, I could see the stock price going to a fraction of the NPV due to mfg cost and other concerns, or double the NPV due to increased credibility of future indications for both L and Direct... but not so sure about 4 fold.
We cheerlead here but we don't pump. There is a difference.
Well... he said "SHORT-ly". A 1 $billion valuation will likely come before 1 $billion in annual sales. But I suppose you might be right.
NPV upon full approval was estimated at $5B. Not sure how long it would take the SP to reflect that. But even $5B wouldn't get us to $100/sh.
I think you are underestimating the lengths that would be necessary to “Let your plans be dark and impenetrable as night", as is truly necessary in NWBO's current situation.
I believe that a minimum of Class A level security would be required.
"a billion dollar company with stock worth $100 a share" That would imply an OS of 10M shares. You might want to check that out.
Actually, Larry Smith didn't say that the attacks led to Jewish people, he said it led to Israel. There are Christians in Israel and Muslims. There are Palestinians in Israel. You brought up Race Adam, not Larry Smith.
Personally, my guess is that Cramer et al started to feel the heat of investigations and started working through a Hedge fund in Israel. Then started the same kind of bashing of NWBO they employed you to do to protect their investments in Celldex, but now protecting their investments in another not-autologous, immunotherapy for GBM, NWBO competitor, and publishing anonymous, from a distance.
A competitor that I hope succeeds and becomes part of the solution.
Adam Feuerstein: Re Larry Smith: If there were Chinese ties, would he be racist to point that out?
There is an Israeli company with a competing phase 3 GBM immunotherapy trial, though it is way behind NWBO. I doubt that the people involved in that trial would do anything slimy, but that stock opened to the Israeli markets about 6 or 9 months ago. People / Hedge Funds invested heavily there might do slimy things if they thought NWBO was a threat.
You know, the kind of slimy things Jim Cramer talked about in his famous video (now on youtube). Making up false rumors about a company to tank it's stock. Tactics he pretty much admitted to using himself at his hedge fund before he left (got booted after throwing a water bottle at one of his employee's head for losing money) and formed "The Street". You know Jim Cramer right? You know "The Street" right.
Go protect Bernie Madoff who was framed and railroaded by anti-Simetics. Or Jim Cramer, the man who created you from nothingness for the exact purpose he describes in his infamous video...
"All that site has in comments is a collection of items from SEC and other public documents. Just a rehash."
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I think you are right about that. But in the bigger picture, as frustrating as it might be for anyone invested long enough to have gone through the two reverse splits, I think they are finally approaching some kind of an evaluation of efficacy for the trial and I think the chance of some kind of approval is significant. I believe that gives the stock much more value than the current share price.
Chris LaCoursiere: Just googled your name. I see. SA Author. Prolific SA Author. Somehow I missed that.
Thanks for so much attention to NWBO and this message board.
Pretend quote:
"There is also some possibility that the crossover arm requested by the FDA and/or other regulators could complicate the application process for product approval."
When I look at it like that I have to wonder how the crossover arm would complicate the application process. I could see it possibly complicating the data... but it doesn't seem to quite fit with complicating the application process.
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Yes, I would agree it is not a perfect fit, but not sure the correct interpretation will ultimately prove to have been a perfect.
"There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval [18]."
Is it possible they are talking about the crossover? Linda Liau put it in similar terms, but two years later.
Never mind that last post about the possible requested changes. I was way back in the posts.
After reading Sentiments post, I will read the line a few dozen more times.
"There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval [18]."
I looked at this for a while before concluding that they probably not saying that changes have been requested... and could be a complication... I think they are saying that complicating changes could be requested.
The reason I concluded this is the use of "and/or".
Neil; I don't want to embarrass you, but I just noticed you have been misspelling your name for the entirety of your postings.
And excellent question... again.
So which was your post about the sponges Flipper? You didn't reference the post number today when you mentioned it. I was going to look at it closely later... now can't find it.
"The good thing about this arrangement is that NWBO is not at the mercy of a company that may not be willing to work with their timeline and needs. So we don't have to worry about a manufacturer refusing to do what we need done when we need it done, and Linda can help oversee the quality of their work, as well."
"I can imagine what a nightmare it could have been for NWBO if BP or the shorts had yanked the strings of their manufacturer to turn them away at a critical moment. That kind of loyalty money can't buy."
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This is exactly how I see it. You look at the Phase V article, for example, and you know there is a force out there trying to ruin the company. Having mfg with a fully independent company just isn't an option, and never was if LP anticipated this kind of aggression.
That doesn't mean that any improper dealings between NWBO and Cognate are OK, but for me, it means I don't care about the small stuff.
As for why the two companies could not be one... I do think LP sees Cognate as the sure thing if immunotherapies are the future, while NWBO is the horse in the race, with an enormous possible payoff. I don't think that is a horrible attitude, I think it is just rational. Even from an ethical standpoint, if she can provide affordable mfg to immunotherapy companies, then she will have done something good. Pyrrhonian would gag at the sound of that given the apparent enormous cost per patient that Cognate has charged, but we do not know yet how much money went into automated mfg development, etc.. Again, I don't care about the small stuff, but the big stuff does matter, so I sure hope to hear some explanation for those costs someday soon.
How to rationalize the lack of transparency on the enormous $ to Cognate?
1) If LP spent a ton of $ on automated mfg development, and then such was not successful, that would look very bad. Not a great reason, but a reason.
2) Making such info public would help competitors strategize.
Afford is probably just shy to talk to you.
Further: Few here are completely detached from self esteem / face issues, ego issues, other social issues, since this board has become home to many after years of posting. To some extent, as offensive as it may sound to the most serious of investors, this board is to some extent, social media. Not to say that there are not deep and true sentiments, by: Sentiment, Flipper, Cherry Tree, ... Afford. There are probably many veterans on the bear side that are very much heart-felt also, having been burned by very similar behaving companies. AVII would certainly be one. He was burned in a more personal way... "Walking Tall" type story. He is angry, and he is very very smart.
Afford has been posting for years now, has told his personal stories, has heard others personal stories... for years. This is home to him and he feels the right to speak his mind. If it gets a little distorted from 100% heart felt 5% of the time... then it is still his honest opinion 95% of the time.
You are new. You came at the same time as a few other new people, giving the appearance of being a paid poster. I'm not sure. You sound ok to me so far, but usually someone with that much invested would have shown up on occasion in the past. Unusual to come out of the blue. About the same time as Woodford the message board poster. Who knows. I wonder if Woodford is Woodford, but then that is how gullible I am. But Afford is real. Whether he is right, or smart to complain while he is holding long is another question. But he has earned his right to speak here over years and hundreds if not thousands of valuable posts. This is home to him. He's just pssd.
Yes... "Immunotherapy" used to (functionally) mean "No Side Effects". The term has been redefined by Big Pharma.
I realize that is not what the term ever really meant, but by the people's dictionary, that is what it came to mean in the last 10 or 15 years, until now, with no apparent notice in the abrupt change.