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Flipper, you're right in my case. And, I'm pretty long of tooth here. We're talking sabertooth long. While reading all the posts with posters' price estimates post good news, I have to admit - it's refreshing change from a lot of the other chatter.
Here's a point of information for other long-toothed friends: When the share price exceeded 12.00 a share back in July, 2015, there were approx. 78M shares outstanding. Today, depending on whose count you believe, there are roughly 325M shares and we're at .17. So, trying to make something at least entertaining out of this, that 12.00 of 2015 would be about the same MC as hitting 3.00 today. And since we're playing this game, it's important to keep in mind that the 12.00 spike was due to virtually nothing! Look how much farther along we are. Look at the partnership possibilities. Other treatments need DCVax to boost efficacy to more significant numbers. Moreover, look at the costs of newer treatments. DCVax will be priced at less than half of the Kite/Gilead CAR-T just approved. And, it might be as low as 1/3 that cost.
Anyway, it's nice to see discussions about post-approval issues for a change instead of stories about why the trial is doomed.
Yeah. I always do my storm windows on the 17th and that reminded me of Yonemura. What happened with that?
So, another example of how inept LP is. Finding a tenant who will be intrinsic to the storage and distribution of the vaccine and who is willing to refurbish the space and then pay a decent rent. Terrible.
Also, what could this possibly mean? Why is LP doing a deal with a company like this when she knows that she has nothing to store or ship? Ludicrous!
I'd think it would be obvious, but, just in case, I'm being sarcastic. LP is always thinking at least 5 steps ahead in this game of chess.
Great job, Leprecon. Thanks
No, but I' am saying that I would never let a post on a message board influence my investment. Would you? Apparently, because you are promulgating this post as true. I say that post is not true.
MD receiving that information would necessitate an 8-k. Therefor, I don't buy it.
LessIsMor: I'm having trouble remembering or locating any document that indicates the BMY partnership with upfront money. Could you post the link/source?
Late-breaking proceedings from It'sDaLaw.com re Yonemura, et al:
Driftwood: Now pay particular attention to this first clause because it's most important. It says the, uh... "The party of the first part shall be known in this contract as the party of the first part." How do you like that? That's pretty neat, eh?
Fiorello: No, that's no good.
Driftwood: What's the matter with it?
Fiorello: I dunno. Let's hear it again.
Driftwood: It says the, uh... "The party of the first part shall be known in this contract as the party of the first part."
Fiorello: That sounds a little better this time.
Driftwood: Well, it grows on you. Would you like to hear it once more?
Fiorello: Er... just the first part.
Driftwood: What do you mean? The... the party of the first part?
Fiorello: No, the first part of the party of the first part.
Driftwood: All right. It says the, uh, "The first part of the party of the first part shall be known in this contract as the first part of the party of the first part shall be known in this contract..." Look, why should we quarrel about a thing like this? We'll take it right out, eh? Now, it says, uh, "The party of the second part shall be known in this contract as the party of the second part."
Fiorello: Well, I don't know about that...
Driftwood: Now what's the matter?
Fiorello: I no like-a the second party, either.
Driftwood: Well, you shoulda come to the first party. We didn't get home 'til around four in the morning. I was blind for three days!
Fiorello: Hey, wait, wait. What does this say here, this thing here?
Driftwood: Oh, that? Oh, that's the usual clause that's in every contract. That just says, uh, it says, uh, if any of the parties participating in this contract are shown not to be in their right mind, the entire agreement is automatically nullified.
Fiorello: Well, I don't know...
Driftwood: It's all right. That's, that's in every contract. That's, that's what they call a sanity clause.
Fiorello: Ha-ha-ha-ha-ha! You can't fool me. There ain't no Sanity Clause!
biosect: I agree with you. As I've said before, the fact the upcoming journal article with be authored by a number of researchers from the various institutions that conducted the L trial who have no direct affiliation with the company, who have first hand knowledge, and who are respected in their field, will be so much more bulletproof than a study presented by Dr. Bosch or a PR from the company. An attack on the journal article would become an attack on the journal, the peer reviewer team, the researchers, and the first-hand, not speculative, observations that the researchers present.
Taken a few steps further, when approval comes, BP can not and will not choose to ignore or downplay DCVax-L. They'll be lining up to test combo treatments. CAR-T needs help, and DCVax can provide it. Legitimate consumer publications will seize on the DCVax story, and the tide will turn rather quickly to the point that the AFs of the world who choose to continue deriding a clear godsend to patients will look to most, if not all, like the absolute fools that they are.
This is all IMO, but it happens also to be true.
That post was a loose thread in the in the string of "Where's Gottlieb" posts.
I agree. I had no idea how prominent PR is in pharmaceuticals. The people there, the VI and throughout the region are in desperate need of assistance. Here's one way to help in PR: http://prfaa.pr.gov/unitedforpuertorico/
Price is history.
It could be as simple as that he didn't realize Yom Kippur begins at sundown and has to travel to be with family.. Or not.
An echo chamber journal. Hmmmm. Where have I heard that before?
Ahhh, Grasshopper. Step by step.
Yes, true. And beyond that, if the 'usual suspects', as Captain Renault would call them, want to take exception to whatever information the article contains, they'll have to take it up with the doctors, not LG and LP. I'm certain that the 'disclosure' the 8-k refers to is going to be the article, not a company PR. I know most get that, but I thought I'd say it again.
Exactly!
You know, maybe it's a language thing because your posts make little sense to me. However, I do give you the benefit of the doubt because I'm a nice guy.
The paper isn't being written by NWBO personnel. The journal article is being written by the investigators at the various institutions participating in the trial. It's possible that Dr. Bosch is co-ordinating it all, so one NWBO person occupied with the paper.
The fact that this is being prepared by investigators from outside the company gives added significance to the article. These investigators treat, see and hear the patients. They are qualified to provide a lot more insight than just cold percentages.
Right. And that 'disclosure", I believe, will be made in the journal article. NWBO have to know that their creds are weak at this point. Why not, since the option is there (and because of the likely embargo), let the news be broken by a world renowned, credible journal in an article signed off on by numerous researchers from UK, EU and US?
I would bet that it means that they were expecting the publication of the peer-reviewed, EMBARGOED, journal article (Thanks to Senti for continuously reminding us that the content of the article is most likely embargoed) prior to the scheduled talk. With just a few days to go, it's fairly apparent that the article will not be public before her talk. So, if that's the case, what would she say? That DCVax-L goes after ALL the antigens? That it's like getting a flu shot? There's nothing of significance that she'd be free to speak about.
This is all IMO, but makes perfect sense to me. Would I prefer that Linda deliver a meaty talk at the conference? Of course, but, as Ecclesiastes the Preacher said, There is a time for every purpose under heaven. Time is soon, just not now.
The sky is falling?
Yes, but CVM had a 1 for 25 R/S mid June. I don't think people see the lifting of the enrollment halt as being as significant as I think it is. Whatever the cause for the halt, and regardless of enrollment having already been closed, FDA have lifted the halt and, in doing so, have given the trial their blessing.
I think that there is a slim to none chance the halt had anything to do with safety.
Alpha. That link is invalid.
Interesting question, Senti. I am guessing, but it seems to me that they would be embargoed for the SMi talk. And, that would be too bad because it looks like SITC is a much larger and probably (guessing) more important conference. So, if they have anything "new and improved" to talk about, I think they may rather do so at a conference with potentially more impact. Would I want to wait the additional 5+ weeks to hear what they have to say? Well, I've waited this long, I guess.
Nice catch.
I don't see a clinical trial number.. I get the sense this was a very small trial. I'll just say that I don't mind having paid the 10.00 to access it at all. Much of the paper reports on murine trials, but the clinical reports, though few, are quite interesting. Because of copyright, I won't cut and paste.
I'm guessing the answer is No. This is a fantastic paper!
Thank you very much for this reference.
IMO means In My Opinion. And, I believe means I believe. But, thanks.
I believe that they had the 400 cohort in mind from the start and therefor chose to use an adaptive design. After seeing safety at the highest dosage, they added the ten to that cohort. If the 400mg arm had caused bad AEs, for example, the patients would be in danger and the trial might have been jeopardized. So, they started with a smaller 400mg group and expanded. IMO
Incredible work, Senti! Part serendipity and part tenacity. One part I want to ask for clarification on, though. When you mention 'the past 24 hours' as a search criteria, are you saying that this adwords buy of DCVax by FDA became active in the past 24 hours?
TIA
Senti: Thanks for sharing that post, I hadn't been aware of it. Timing is quite interesting, and I hadn't even considered calibration and consistency issues before.
This is an interesting theory, but I have one problem with it. Paraphrasing a comment made by Linda Powers after the halt was made public, she basically said, 'They're trying to turn good news into bad.' I can't make a connection between that comment and your tempting theory. Can you or anyone?
A theory that I'm more comfortable with is that either the DMC or some member thereof or the FDA saw what appeared to be an unusual amount of early progression and concluded that that meant failure of PFS. This would be the bad news. What the company were aware, and becoming more and more convinced of due to numerous data that were becoming available, was that immunotherapy can and often does cause inflammation of the tumor due to necrotic tumor tissue, infiltration of T-cells, etc., and that inflammation causes imaging to show an increase in tumor mass which would, according to measures established for SOC, otherwise indicate progression. This would be the good news. Inflammation=immune response. Wouldn't DMC be aware of this? Perhaps, but if the protocol was written in such a way (remember, it was created a few years before this time when a lot less was know of the effects of immunotherapy) that mandated assessment of tumor growth via imaging, then inflammation (i.e., immune response) would be reported as progression of the disease.
I know that there are differing opinions regarding the incidence of apparent pseudo-progression due to DCVax. That there are significant numbers of cases of treatment-induced enlargement is my conclusion.
And, getting back to Linda's comment from that time, I find it interesting wording. I am fairly certain that she said, 'They're trying to turn" good news into bad. Who are They? And, if they are trying, doesn't that mean some intentional activity? The question remains open. However....
All good points.
Of course you are free to express your concerns. I didn't mean to imply otherwise. Look, I got in to NWBO even before you. No contest or anything, I just am saying that to tell you I've been around the block with NWBO more that a few times. And, maybe my post sounds all confident and pedantic, but I go through similar angst as you're describing. It's not fun. I know. But, I continue to do my DD and despite all the dross thrown out on the MB along with my own fears, I try to be reasonable. And, when I am, I see that the empirical evidence points in a positive direction.
My initial comment to you was more in the way of something to, perhaps, allow you to see that there may be another point of view, and, in seeing that, help you reduce your anxiety about your investment in NWBO.
Again, I'm not here to proselytize. Just throwing out something to consider.