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You are talking about Neil Woodfords publication today, right? If so, I would agree that I did not read it as aggressive or divisive. He has huge losses that he has to comment on. He complains about never finding out what was behind the recruitment hold... a reasonable complaint. And makes sense for him to take a clear stance, defensive but not aggressive, as that court case comes to a critical point (which may or may not be extended in spite of the judge saying that it won't be).
Normal stuff it seemed to me. I agree.
But I am now recalling all the nasty stuff with the apparent bad-girl plant by Woodford on his investigating committee, etc... . Was he duped there, or was he trying to pull a fast one? Ancient debate. Very sensitive topic. Strong opinions. I had sort of forgotten about all that.
I don't know. I thought he might be aligned with Phase V. He had taken over another company and was famous for it. But... not so different from accusations about LP. Hard to know for sure what is going on. Room for positive or negative realities between very few facts.
To me the agreement by both parties to delay the (Yonamura?) court case points to mutual expectations of more cash to bargain with down the road. You can't get blood from a turnip... (but can you get shares from Cognate? why not? Maybe she (Yonamura) doesn't want shares.)
I had forgotten how nasty things got with the Neil putting a competitor with an ongoing lawsuit on his independent investigating committee, etc.. It's been a while.
It certainly looked bad.
They were waiting for a tally of PFS events... right? Blinded, but a tally of total PFS events. They thought there would be about the right number by now. So maybe there was not the right number yet. That would be good news.
I'm sorry if that sounds lame, but there is some possible truth in it, as usual. And that possibility is, I believe, what keeps the longs hanging on. Everything is always ambiguous. May be a big plot. Maybe not.
But we are approaching a data readout I still believe. And we will finally see if this works.
Earlier today I finally tracked down a related therapy that I had heard about on this board years ago. Turns out it was trialed by a private company... and it got approval, years ago. By no means the same therapy, but close enough to give me great hope for this one. DCVax-L is a more complex, supercharged version of the one that got approved. That doesn't mean it is better, but it might well be.
That has always seemed like somewhat of a possibility to me. He had done that recently with another company (Hostile Takeover). To give him the benefit of the doubt, if that was his intention with NWBO, maybe it was not so much Tin-Man greed, but a true belief that the company, though on to something valuable, had major governance issues, and he was just the guy to straighten that out. That is pretty much what he says in this publication.
Right. Iff there was no look at the data, as the company says, then the recruitment hold was not due to efficacy, and the odds of success have only dropped by the small amount that the lack of 17 patients would effect. Which can be compensated for by waiting longer.. I think; and perhaps has been compensated for by waiting longer.
"So your sayin' there's a chance Neil"
I am just a goofy guy who liked that line in that goofy movie.
I'm pretty sure Woodford bought in before the recruitment hold. Any guess at the odds of approval do depend on what you allow as the possible reasons for the recruitment hold. Many here have come up with reasons that have nothing to do with efficacy.
Never mind... it was 5 weeks ago...
So your sayin' there's a chance Neil!
Glad to hear it!
--------------------------------------------------
"From here, we wait and retain hope that at least one of the trials reads out positively. This is something which, given events, we would apply a lower probability to now but, nevertheless it is certainly possible.
Regards
Neil"
Call TD about your options. Don't wait. I talk to them often. I don't know why they won't sell.
I got my delisted options education this time around the block. I didn't know the delist would effect the options. I had a ton of Jan 2018 $7.50 calls that I had gotten at 5 cents. But I saw some $3 calls the same date selling at 5 cents so I bailed on mine when the opportunity arose, with the plan of buying the lower strike options during the next dip in sentiment. But when I put in my bid I was informed that those options are sell only.
When I asked about this they (not sure it was TD I was talking to at that point) said that the only allowed buyers would be the people that offered the options to begin with. That they had probably been ordered to buy them back. Maybe there was a deadline to do so... or maybe the options are actually dead. But I don't think so. I would call right now and ask if I was you. If TD doesn't know, you might try to get hold of someone at Options House.
Sounds good. So you think they may be waiting for a reply from the FDA regarding NWBO's final, final proposed subgroups scheme, or some other related issue.
I like that. I like it because I don't remember them talking about mesenchymal as a subgroup in the past, and I want to believe that subgroup shows great response.
Mesenchymal more immunogenic... why would that be? Less blockade function? If so, then clearly it would have to have other things going for it, as a cancer, that offset that weakness. But perhaps those other things are no match for DCVax-L... if it does lack blockade function.
"Hypoxia significantly inhibits the infiltration of immune cells into tumor tissue. Bevacizumab is believed to normalize tumor vasculature and decrease tumor hypoxic area."
Seems counter-intuitive. Don't tell the people at VBLT!
At the point that LP decided to invest massively in DCVax-L mfg infrastructure she created a "Failure is not an Option" situation. In that situation, a logical change to the trial would be to trade the alpha spend that would normally be used on early looks at efficacy for defining new subgroups.
I said this before but also speculated that some whiff of marginal efficacy might have been part of the motive. Just want to point out that this is not necessary. The sequence of events makes total sense without such a whiff.
That is... if such a trade in alpha spend is allowable. Not my forte'.
My impression is that there is some alpha spend allowed before it begins to raise the bar for approval. If so, it may have been within that initial allowance that they maneuvered.
But again... I don't know much about such things. Just hazy recollection of what others have said on this message board.
Maybe your right Kabunishi, but my first read on Extremist223's post was that it was an honest accounting of his impressions as they had formed. Impressions which he wants to fit together to finish the puzzle, but has not been able to accomplish yet. Right now he can only stand back and blur his eyes a little and then ask his gut what to do. And his gut told him that the trial would succeed.
Your post sounds good Dan.
But one could argue that it is a different indication, being recurrent GBM rather than new GBM. That is the question... would that be enough of a difference in indications for the FDA to ignore a futility finding for the first?
You answer your own question: see part 2).
Why would she sell off a large chunk of the company so cheap?
1) She is in the home stretch of an expensive phase 3 clinical trial and out of money. She has to fund the trial. To do that she has to sell shares. What price can she get?
2) "She appears to have pissed off common shareholders one "fat cat" investor and lost major upside possibilities for shareholders along the way. Again, most shareholders are long gone and damaged beyond repair."
I had missed that point Chinatown. The fact that L is approved as part of a combo therapy does not mean much, bu the fact that it was approved for one leg as a monotherapy... that says a lot. I get your point!
Maybe you are right there is failure in the wind. But if LP gained any such foresight, it was not certainty of failure, but rather odds of failure. I say that because she went to great lengths to increase odds of approval late in the game by setting up multiple subgroups and forgoing the alpha spend associated with early looks at the data. Both her actions and LL's recent statements point to continued hope of approval for some subgroup(s) which puts the proper valuation for the stock much higher than the present value in my opinion.
Further; even if approved for only a subgroup, if the data suggests that it was only the trial design that got in the way for other subgroups, then the potential for DCVax-L will have been confirmed and credibility will have been regained for NWBO and LP as well.
I am only going to say this once for a couple of different reasons. But if I were Cognate facing an eminent legal finding where I might have to cough up a gazillion shares of NWBO stock, I might want to accumulate those shares on the cheap... even if I had to do it in a round-about way. And I would want to do that before the finding. And I might prefer to do it under whatever degree of darkness comes with being de-listed.
Maybe DCVax-L and the Placebo will both get FDA approval!
"They can but it would need to be reported the same time frame as if LP bought it herself. Because LP is the voting head of Cognate."
That's all SEC, and not NAS? Does the move to the OTC effect/relax that requirement at all?
Can Cognate buy on the open market?
If they did, how soon would we see it in SEC filings?
Why keep NWBO around if L GBM approved? If Direct proves out this GBM indication will be a drop in the bucket. Further, there are many other possible indications for L, including Prostate if the big dogs get involved as partners. I don't know if Cognate could carry all that. Maybe. But that is what you would have to visualize happening. The Direct trials all moving over to Cognate. All new trials moving to Cognate. Would the relationship with UCLA be maintained if LP became an infamous retail investor scrwr? (of course some claim that is already the case).
I don't know if all that happening has much advantage for LP over staying the course if L proves out here. The future potential for the company would become so enormous that it just wouldn't make sense to mess with it in my opinion. Though I do understand your concern... but also wonder if you (BioBoom) want to put in a temporary stop at $5.88 so you could still get in if approved.
$5.88/sh on Great Results!!! What? Buzz Kill
So you think Woodford might almost break even on great results? Woodford must not be very good at investing.
Your 170M shares might be accurate. I assume you are including outstanding warrants. But $1B for outstanding results? GBM alone has a net present value of $5B on approval according to a major league source. That would have to be for great results on the broad GBM population, thus full approval for all GBM.
Right now, more realistic might be a $3.4B valuation. That would be about $20/sh. That was Smith's estimate. I think it could reach that with approval for half the GBM population. Why not linear? Not sure... just think that is where it would go. If you look at Celldex's GBM trial and what % population it covered and the valuation that was expected on approval, I think you would come to about $20/sh for us at half the GBM population, if it is an easily identifiable half.
Many drugs are applicable to a specific cancer. DCVax-L and DCVax-Direct are applicable to all solid tumor cancers. So approval here would set a panic in the hearts of some Big Pharma's. The panic of being left out. You know that panic as a long investor in risky biotech stocks. So much higher buyout valuations are possible if the right companies get worried.
Thank you monentum2play.
http://www.immunotherapyforum.com/immunotherapy-world-2017-agenda
Which Conference? No PR about it? LP speaking? An abstract?
I understand your concern that NWBO might be a tool for Cognate. But abandonment after hypothetical approval sounds very difficult with people like Woodford invested. A move like that, at that point, would be so transparently slimy, that LP would be nailed to the cross quickly in the courts if there was a strong effort by investors to see that happen. And Woodford would be on that immediately... again, unless she managed to work some under-the-table deal with Woodford. That would be what the smaller investors would want to scrutinize.
Myself, I still have hope that LP has no such malicious plans, and that all the dramatic SP drama has been a result of Ph V and the hold on recruiting patients combined with the basic survival needs of a Phase 3 clinical trial.
I was serious. It does make total sense. Maybe :) :) :) was in reference to my wild speculation... with such a simple explanation in front of me. If so, I would agree, :) :) :). But I am not too surprised.
Ah! Yes. Thought L = Lung. That makes total sense. Thanks.
I wasn't speculating that this was actually a lung cancer mets trial. What I was speculating, though admitting is extremely unlikely, is that DCVax-L is getting approved for lung cancer based on data from the GBM trial. Seems very unlikely.
Maybe there is also a lung cancer trial in the works for DCVax-L and somebody mixed the two up.
"Oops! I just tried to pull up the trial to check sponsor info and now that NCT trial has disappeared."
If you search the clinicaltrials.gov site with "DCVax-L" it does not show up. You get only 5 hits. If you use just "DCVax" instead it shows up as #7.
Lung METS from GBM? I know that at least some lung cancers can initiate METS in the brain, but does GBM sometimes initiate METS in the lungs? Often enough to form the basis of an approval from a 3XX patient GBM trial?
So how do you know that IC light? You have seen data that delineates the different crossover patients?
That is funny. But something else is funny here. The whole Lung thing, and Northwest is not mentioned on the page as far as I can see. Maybe this trial was designed by somebody else so NWBO was caught off guard by the timing of the clinicaltrials.gov listing. Maybe NWBO has a lung trial also in the plans and reformulated a tad for that trial, and that this trial wants to use that reformulation. Seems likely they would reformulate with anything and everything they have learned in the last 10 years if starting over from phase 2 on any indication. This regardless of how well DCVax-L has been working.
One explanation for the lack of PR's, if only believed by us that can see LP's halo, is that they are being super careful not to poison the trial legal issues by saying too much. That would fit here.
Yes Crossover in an OS trial would be difficult. Good point. Very uncooperative patients.
DCVax-L Lung: That is noteworthy to say the least! A great mystery for now. I did just check to make sure that "DCVax" is trademarked... and it is. So... let the speculation begin...
1) Typo was somebody's guess.
2) They noticed that everybody with lung mets in the DCVax-L GBM trial was cured of those mets, so they approved DCVax-L for Lung Cancer in general.
3) I have no idea. This is very bazaar. That would be one hll of a typo and it repeats itself all over the page... I think 12 times. While guess #2 doesn't seem all that likely either.
Primary endpoint OS but no crossover, right?
I meant planned number of events, not primary endpoint.
"If reaching the primary endpoint is the news you are looking for, then she doesn't have control of when she can update that."
I doubt there is anybody expecting efficacy results any time soon, but just in case: I am pretty sure there won't be any. They have to grind the data for a very long time, legitimately, and apparently, they have not started yet. Any news about the trial would be about the planned number of PSF events having been reached... unless they are holding out for OS. Stuff many others here understand better than I and have likely spoken about repeatedly of late.
If reaching the primary endpoint is the news you are looking for, then she doesn't have control of when she can update that.
The holidays are not a great time to get things done. Most of the employees where I work disappeared a full week before Christmas and just returned yesterday. She doesn't have control of all the clinics that need to cooperate with updating data. If they do not have the numbers with what is reported, any single hold-out could put her in the position of not being able say anything.
But maybe she should change her pet phrase from "Stay Tuned" to "Stay Fumed". At least if her allies are accumulating, that phrase would work well.
"99% of which is phagocytized at the injection site"
You had two primary points equating DCVax-L to a similar therapy that failed in trials. One was an overwhelming of the immune system, whether paths for DC travel to the lymph nodes, or crowding in the lymph nodes themselves. The other was this issue of the DC's being phagocytized at the injection site.
Let me ask you regarding that other study: Did they use the same "teenage" DC's? If not, there is no comparison regarding the ability of the DC's to avoid the macrophages. Macrophages are like sloths. Most DC's are like turtles, and vulnerable to sloths. Teenage DC's are like squirrels... no that's not it... they are like Jaguars! Yeaah! That's the ticket!
Regarding the overwhelming of the immune system: Northwest addressed this issue empirically by spreading the DC injections out over time and space (thank you Doc Logic). Did they do the same in this study that you often used as a comparison? It seems doubtful that they used the same process in this regard.