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Hmmm - maybe that explains the April 7 call action Long has been seeing lately
I assume there would be no recommendation for a halt unless Dr. Furberg was absolutely certain of the outcome.
AVII pointed out something I thought was quite interesting. Dr. Curt Furberg, the DMC chairman and thus the one who would make any halt recommendation, has advised the FDA over many years (regarding drug safety), has extensive experience with clinical trials, and has literally :written the book" (co-authored) on clinical trials Fundamentals of Clinical Trials.
You would think that if LP could trust anyone to know when a trial should be halted, including the level of efficacy which would be acceptable to the FDA, that person would be Dr. Furberg.
Hi Regina - I think the disagreement is between those who have a penchant for "interpreting" and those favoring sticking to the plain meaning of what Linda says.
I'm in the latter camp because I am a firm believer in the Law of Occam's Razor.
Happy Holidays!
Hi staccani - your percentage is slightly off, 90/232 = approx 39% but your speculation is interesting. I suppose if L were as efficacious as we wish it were, 39% would be the low range.
Hi Regina - of course we all know there are subtleties and nuances and maybe a DMC halt recommendation would be followed. All I'm saying is that what we now know is that there was nothing "lost in translation". In other words, if you or any other of us besides the four had been there, we would have heard the same thing. She said she wasn't gonna halt. You can spin that any way you want, but translation error it ain't.
Letsgo
Thank you very much for attending and relaying this information.
Let's hope it's clear to everyone now that there was nothing "lost in translation" (Flip excepted of course).
It's pretty funny alright Goldilocks
Worth posting directly IMO - and will save having to see the name of that horrible creature
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Hi Pyrr
Hi sentiment
You bring up an interesting point. Today we were told that NW intends to continue the trial through to completion even if they receive a recommendation of halt for efficacy from the DMC. You speculated we could get a "window" into PFS and OS partways into 2015, when, presumably, a DMC review for efficacy would occur. Your unspoken assumption was that, if the DMC did conduct an efficacy review, NW would PR the recommendation, even though they wouldn't follow a recommendation for a halt for efficacy.
By the way, there is no "report" on efficacy. There is either a halt or a continue recommendation. If the trial was halted, then we might expect a report, because the trial would then be unblinded.
But anyway, getting back to the main point, at this juncture I wouldn't know what to guess. Let's assume the DMC actually does an efficacy review. Would NW PR it? Perhaps if there was a strong recommendation to halt for efficacy, they might, even if they're not going to halt. On the other hand, if it is a recommendation only to continue, which would suggest results are not particularly outstanding, then maybe they wouldn't PR the recommendation. But if I was Linda Powers, I would realize how the two alternatives above could be interpreted by such as the people who are watching this company as closely as we are. I would think that she would realize that managing expectations is important because if we are expecting a report on the DMC efficacy recommendation, then the absence of one would be a negative. Therefore she is creating a state of ambiguity - we're not going to halt the trial even if the DMC recommends we do so. And I think this suggests, in her mind, that there will be no PR, because it would be about an event that makes no difference anyway because they're not going to halt the trial. My best guess is she's not counting on the trial to demonstrate overwhelming efficacy and early termination. I think that's pretty clear from the trial revision, the position that they wouldn't halt even in the face of a recommendation from the DMC, and one or two other things which I can't recall right at the moment.
So, no, I don't think we're going to get a PR about the DMC efficacy review. I can't imagine any reason why they would rule out halting the trial for efficacy if there was any chance that would be the recommendation.
I continue to believe the Phase III outcome will be successful.
Thank you sir!
Regina
What a difference a word can make. "All" could refer to all agencies involved, including the PEI conditional approval. Couldn't she have instead used "full" or "complete" if that's what she meant?
I submit she didn't because that's not what she meant. She is a lawyer, right?
from wikipedia
Hi Eval
Interesting.
Eval
Two comments.
Evidently Belgium has their own version of DCVax-L
From the March 10 PR
Hi Regina
Right.
Ah, good, thank you:
OK. Chemnitz is a different trial site than Dresden. Good. There should be at least 6 others from the June PR.
Hi Luna
Here's the Google translation. The flyer title is "recruiting clinical trials", unfortunately there are zero patients so far for DCVax-L thus the possibility that enrollment is being held up can't be positively eliminated. Can you find out where the hospital is located?
DCVax
Clinical phase III study to assess
DCVax®-L, autologous dendritic cells (DC)
pulsed with Tumorlysatantigen, for the treatment of
Glioblastoma multiforme (GMB)
Duration: 2014 - ongoing / number of patients: 0
The person I emailed should be a secretary or other clerical person who's job it is to answer inquiries. I didn't identify my interest so they would not have known I was an investor. It is the contact person listed for patients in clinicaltrials.org. I was only half (or less) expecting a reply. Maybe you could inquire on behalf of a fictitious patient?
Thanks for the response Pyr
Hi Regina
Everyone seems to be waiting for HE reimbursement numbers. I'm waiting for the following:
1. Final PEI approval of the clinical trial changes.
2. Activation and enrollment of the 7 trial sites in Germany which were "initiated" in June and July.
3. And, like everyone else, finalization of HE reimbursement schedule.
The "militant" (to borrow a phrase from Pyr) bullish faction has declared final PEI approval to be a mere "formality" and insists the trial has been ongoing in Germany since the announcement of the changes last August. However, the fact that we have heard neither that the PEI has granted final approval or that the 7 trial sites have begun enrollment strongly suggests otherwise. It has been argued that NWBO wants to keep the beginning of enrollment for these 7 sites a "secret". I find this contention utterly ridiculous and completely contrary to behavior of the company in the past.
More speculatively, it also appears that there may be a connection to resumption of the trial and HE reimbursement negotiations. I made the point some posts back (to sentiment_stocks) that if the trial sites are also where the treatments are administered under HE (which I believe we were told by Linda), and there is any question whatsoever as to whether or not the site will activate, and thereby permit the HE treatments, then it would be reasonable to assume that the HE reimbursement negotiations would be suspended pending resolution of the matter. Note this argument does not apply to the Dresden site, which we know has been activated and has, as far as we have been told, accepted one HE patient.
Yeah, it would be great if there were dozens of patients in the clinical trial at all the 8 sites we know of now but you know what? I'm not a betting man but if I had to I would bet that the 7 sites we were told about last June have not started enrollment pending final approval of the PEI, and, further, there's a chance, I'd say 50-50 at this point, we're not going to hear about HE reimbursement until they do.
My $.02 LOL
Thanks...
Would you ask him if the PEI has given final approval for the trial changes yet also?
From what I can gather it results in the release of IL-12 at the injection site in the tumor. Direct already does that and much more, so I don't see it helping Direct. I would think of it more as a potential competitor.
Well, good point (love your new "avatar" BTW) but this has to do with the individual trial sites. My concern is with the PEI approval, which precedes the steps you are referencing. Once the PEI signs on, then the negotiations with the different trial sites starts (or, in this case, restarts). Regarding the trial sites I would expect some economy in terms of time since it has already been done once before. I'd like to hear Lunatick's thoughts about how long it could take for the PEI to approve the, presumably rather modest, trial changes (6 mos?). And, would somebody email Les and ask if the PEI has given final approval? TIA
Senti
well - I don't see how they can proceed at any trial site, including Dresden, until they wrap up negotiations with the PEI about the changes. They can't just keep on with the old trial, and until the new one has all the wrinkles ironed out they can't start. After all this is Germany. We're still waiting to hear that the negotiations have been finalized - unless they're keeping that a secret too, eh?
So, are you gonna take me up on my wager?
Well - I was taking my manner cues from some of your responses to other posters. But, fine - let's play nice, that is always my preference. So, to start off in that vein, you were right, I was wrong. "Trial site initiation" - I and several others were confused by this. I went back and reread the PR very carefully . It turns out they are using "initiation" to mean something that happens at the end of a process, whereas normally you think of it as coming at the beginning. To complicate matters, for the German sites it's neither at the end or the beginning of the process. So, confusing, and another reminder that I should always read it myself and never rely on someone else's interpretation.
That said - the question of German site initiation remains. At this point we both agree that the 3 June sites and the 4 July sites should be active by now according to the timeline laid out in the PR. You contend that they are and we're just not being told about it. I consider that wishful thinking. I've done a little research, so let me try to make my point as clearly as I can.
There was a PR on 8-11-14 announcing there were now more than 50 sites, a "number" being in Europe. In the latest 10Q current as of 9-30-14 there are now more than 60 in the U.S. and Europe. Now, if you go to ClinicalTrials.gov and use the History of Changes feature, you will find that as of June 13, there were 60 "active" trial sites (3 sites had been withdrawn by then). 58 in the US, 1 in the UK, and 1 in Germany. Thus, as of the 8-11 PR, more than 50 (check) and a "number" in Europe (check - the number being 2). Of course, you could also include the sites that were withdrawn, but that would mean the statement "more than 50" is still true - 61 is still more than 50. It is entirely possible that the 10Q statement (more than 60 in the US and Europe) is based on this. Someone at the company might have gone to the trouble of actually looking it up (which they didn't bother to do for the 8-11 PR). It's also possible that they were counting sites that had not yet been added to ClinicalTrials.gov. Sites were added on 10-21 (1), 10-30 (1), and 11-2 (4), 6 in total, in LA, Lexington, KY, Valhalla,NY, Oklahoma City, Winston-Salem, and Atlanta. But the question is would they add US sites and not the German ones that were supposed be be active already?
It doesn't wash.
I wouldn't put too much credence in these site numbers provided by the company in their PRs. Someone could have counted, like I did, for that 8-11 PR, but they didn't. They just knew it was "more than 50" so they went with that because it was "safe" from a lawyer point of view.
Whatever motive you might think NW has to keep the German sites under wraps, I think it's just the opposite. Linda has not been known to be shy about promoting the company. In fact, I think the strongest argument that the sites are delayed is that NW would want the whole world to know about it if they were up and running.
It may well be connected to the trial changes. We still have not heard that the final negotiations with the PEI have been completed. That could well be what's holding things up. In fact, I'd wager a cream soda on it ;)
You can just sit tight with your stock holdings knowing eventually you will very likely be rewarded, but some of us, like Evaluate and others (including myself) are trying to improve their positions by using call options or buying on the "lows". You have earned yourself a position of respect on this board, and others less certain of their own judgment may look to you in making their investment decisions. I don't think painting an overly optimistic picture is doing anybody any favors, especially regarding short-term performance. GLTA
I'm having a little bit of difficulty following your logic. You said:
Good point.
I don't really understand the debate about L site enrollment. As you pointed out, it clearly shows 69 sites on ClinicalTrials.gov. 1 in UK, 1 in Germany, the rest in the U.S. broken down as 3 withdrawn, 1 completed, 4 not yet recruiting, and the rest Active, not recruiting or Recruiting. So you could say there are 64 sites overall or 59 "currently active" in the U.S.
The company PR saying 51 sites is way dated. Someone posted about 10 additional sites quite a while ago when we were hoping German enrollment was ramping up but they turned out to be U.S. sites. So, we're still waiting. Some have speculated that Germany sites are waiting for HE negotiations to be finalized. I believe Linda mentioned recently those sites would also be where HE patients are treated and that might explain why they haven't started yet. That's speculative but who knows? We're all getting frustrated waiting to hear about HE and PIII in Germany, some more than others...
Thanks.
So the RNA is Messenger RNA - this means the DCs are translating the RNA and producing the antigens themselves. That is interesting!
Pyr re Argos, any thoughts on the difference between using tumor RNA vs. tumor lysate to prepare the DCs?