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Submitted for your approval -- (pan to Rod Serling)
Linda Liau submits to SNO at the last opportunity and scores a pretty, pretty good slot in the program. (insert still of Larry David). What's up with that?
Consider, if you will (Serling again trying to keep cigarette smoke out of his eyes), that at soft lock LL saw the final blended data. She may have run Monte Carlo sims on it, or she might have honed in on a specific telltale indicator like T-cell load in blood draws, or, most likely, in my mind, she just had an intuitive sense that we had a home run. So, she immediately submits to SNO telling them, I don't have top line at this point, but will by the conference. And, BTW, it will be noteworthy. It's not on her rep or due to any favors that they accept the submission, IMO. She made a good case that she'll deliver important information.
As for the 'delay': I and others have been here a long (8+ years) time. The company are not known for their on-time arrivals. Overzealousness? Maybe. Subterfuge? I think not. Would it have been better for them to put out a Band-aid PR explaining the delay rather than allowing the price to drop back as it had? In the long run, no. What difference does it make if the run up is from .70 or .90? I'm in other stocks (take IPIX, for example), who've issued what I would call Bad-aid PRs in an attempt to shore up SP, only to see them backfire.
Hopefully, we'll emerge form the Twilight Zone this week with some info.
'nuf sed
I considered what you said in your first statement as I was writing my post, but I still think there was some sort of SNAFU. Nothing tragic, but still necessary to clean up before hard lock. I'm inclined to believe that DL has not happened yet. Am I happy? No. But, I can set the Way Back Machine for 2015 and think, would I like to be back here, or here, now, waiting? Even if it takes three more weeks.
It's first and goal. No time to risk a fumble.
Believe me, I'm not unfazed by yet another failure in on-time delivery by NW. I'm finding it particularly stressful due to s perfect storm of black swan type events in my life this past year and a half. Any potential profit from my investment has gone from being nice to almost essential at this point for me. And, the culmination of 8 years of waiting adds it own stress in the anticipation. I vacillate from hand-wringing to rational appraisal of the situation.
My rational moments tell me that being late for NW is to be expected based on what I've seen in the 8 years I'm here. Am I ready to say that they're guilty of anything other than sharing their expectation based on information available to them at the time? No. For example, consider that the CRO checks the data and finds something missing or improperly reported from one or more sites. Of course, they contact the investigator and ask for what's required. Now. it's in the hands of that site. It's quite possible that the investigator may not share our urgency and it takes a few or more days. Well, Initially, the CRO could have told the company, we have the data and according to our experience, you should be good to go by the end of Sept. But, they're waiting for Dr. X to respond. So, what looked likely
three weeks ago is now impossible.
If the above is close to accurate, would it have been nice to hear that there was a delay due to some incomplete data? Of course. And, I can't guess why they wouldn't issue an update once it became clear that time was now too short to have TLD in Sept. So, what to do?
To try to stay as sane as I can, I look at what is known and try to avoid inferring anything or accepting other's inferences. What's known is that the top 100 patients did phenomenally well. What's know is the data on Linda Liau's slide comparing DCVax to Novocure and Opdivo. These are empirical examples I look to. Whether LL had access to TLD prior to submitting her abstract for Nov. I'd consider, personally, to be in the realm of inferences.
So, I have three options now, as I see it. Hold, sell, or buy if we are hit hard on speculation again next week. I'll be buying if that's the case. Nothing but an anticipated schedule for DL, analysis and TLD has changed, and we don't know why. But, look back. We've got enough black swans in our past to stock a pond at Sawston and open a tourist attraction if all else does fail.
Thanks. Been here since 2012 myself, and yes, their on-time record is dismal. Yet, LP did make a point to add to her Powerpoint in red letters saying TLD would come by the end of this month. That was just two weeks ago.
Curious whether anyone has spoken to LG or Dave Innes in the past few days, and, if so, how did they sound? Presuming they are actually on schedule and LP's slide was accurate, they have to have data by now because LP said repeatedly that it would take the statisticians a few weeks and then some time to take their work and put it in a form for general consumption.
Would suit me fine. But so would 50bn. Somewhere in there.
Hey Marzan! Thanks! Well, Astavakra was an ancient sage in India who professed the teaching of Advaita Vedanta. Astavakra itself means eight afflictions, because supposedly he was born with those. He wrote about how liberation could be attained through knowledge, in a nutshell.
I've been on a long holiday from the board for mental heath reasons, so to speak. So much nonsense. I've been accumulating during my absence.
No. I enjoyed the music and especially what they told us.
Longfellow, Thank you so much for sharing this .
I took 1000mg Tylenol 4x a day for about 10 days until my stomach got upset. Plenty of liquids/gatorade.
I'm at a loss for words. But, thank you
Oh no. Here in NYC masks are all the rage. Not those shabby pleated blue and white paper jobs. We're talking designer super hero looking things.
Hi Captn. I'm so sorry about your losses. I had no breathing difficulty throughout, fortunately. I understand your tests were negative. Did you experience any smell or taste issues? I'd take those to be a more definitive indicator of the virus than the tests, just IMO. I stress, just my opinion.
Hah! you're right. I was out today and people were looking at me like I was Typhoid Mary because I wasn't wearing a mask.
Hi All,
I've been laying low in general on the board for several months. Everyone seems to be getting along without me just fine. Not that I doubted that would be the case.
I do want to report that I have come through the other side of COVID here in NYC. I started with symptoms on 3/17 and was tested that day. I got positive results on 3/19. I did not develop breathing issues, thankfully, and I was able to ride it out at home. It was two weeks of non-stop fever, ranging from like 99.5 to 102. Along with that, sweats, sweat and sweats and very bad back pain. I could barely sleep as a result. I also lost my sense of smell and taste, however food tasted just horrible. Extremely salty and sweet. I lost about 10 pounds. I've been fever free for a week now. My taste has mostly returned, but it's still not right. I've contacted NYC Health and Hospitals to donate plasma. I hear that one donation may save three lives.
I was outside this afternoon. It is very eerie here. There are lines outside of stores with people standing 6 feet apart. Stores limit the density by some formula, I don't know what it is. There is virtually no traffic that I can see.
I wish everyone well. If you do come down with this virus, hang in there. And, if you do experience breathing difficulties, go straight to the ER. Time matters in that case.
Hi Ike:
3, 6, 9, 11, 17
Hehehe.
I, for one, have spoken with DI. The sum of our lengthy conversation is this: use reason, not feelings, when assessing the publicly available information. Aside from that one difference regarding DI, I agree with your perspective 100%
I’ve been here for 8 years and can say, with complete certainty, that any timelines, real or imagined, aren’t to be taken seriously. But each day brings us one day closer to something.
Evaluate - I think you are spot on with your interpretation. It's less about the actual translation of Sicherheitsgründen than it is the interpretation. Consider, for example, that something perhaps was discovered as being amiss at some site, not with the safety of DCVAx, but rather perhaps the way it was administered or even labeled, and to ensure it wasn't happening or likely to happen elsewhere, the trial was suspended. ( By the way, the word unterbrochen does not mean halted. It means interrupted or suspended.) So, "just to be safe", (Sicherheitsgründen), it was halted in Germany and elsewhere, as well.
Thanks for sharing this reply from Ehrlich. I notice at the outset of her response she apologizes to you again for the late reply. Did you get a communication from her prior to this one?
One of us is misreading the other's post.
Good post. Conventional wisdom is generally based on the most superficial evidence. Admittedly, it might be the best evidence available at the time. Look at pseudo-progression. Just a few years back, any increase in tumor size was considered an indicator of negative outcome. A problem of conventional wisdom is that it can establish the red herring that throws hypotheses off track and potentially misinforms important decisions, like DMC recommendations of futility, as an example, where, in fact, enlargement is actually the result of a very robust immune response to treatment.
New study out today in Immuno-Oncology News. Not DCVax, but interesting read:
Specific Gene Mutations Predict Success of Immunotherapy in Glioblastoma Patients, Study Reports
Woodford filed 13G. Looks like an update on % held.
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Thanks Ike.
Yes, 31. I just couldn't recall as I was writing and was lazy. I can't opine on whether FDA would care. I tend to doubt the comment that they wouldn't care whether NWBO revealed the reason, because FDA will not comment at all on any specific trial.
You make a good point. Here's another possibility. FDA has and had access to the data in some form (I suppose blended data). Within a couple of months of the halt, Linda Liau made her now-famous comment that 'they're all living longer.' It was around that time that I had a conversation with FDA wherein I asked if they ever halt a trial so as to prevent additional patients from receiving placebo as that would, I said, be unethical. I was surprised to hear that, yes, it's been done and is determined on a case by case basis. Remember shortly after the halt, Linda Powers said about NWBO critics something like, 'they're trying to turn good news into bad?' What good news?
Flash forward to a short time back when it was determined that the last group of patients enrolled, (I forget, was it 11?) were all put into the treatment arm. Why?
So what would be a reason to delay unblinding at that point? The same reason why we haven't yet had unblinding: after all that the company and its shareholders have endured, the absolute worst mistake would be to unblind too early before indisputable success could be demonstrated. And you can bet that AF and the like have already been preparing their arguments to try to discredit any sign of a successful trial.
So, like virtually every other long my patience wears thin, but there are positive signs if one looks for them and sees all the theories of doom and gloom as some sort of dark pastime that some people choose to busy themselves with. I've found it also helps if I drop in on the MB now and then just to see what the latest topic is, but otherwise avoid reading it. So, if you haven't read this post, IMO you have the right idea ;-}
I still think it was done by aliens
How long does it take to say that "top line data will be available on _____, 2019"? Took me 4 seconds.
As for share price after her talk, I couldn't care less. Price will move significantly when it's time.
LP to speak 1/23: DCVAX Personalized Immune Therapy for CancerPhacilitate Agenda
I'm expecting that we'll learn significant new information from her talk. No way would she repackage old info at this point, IMO.
Excuse me if this has been posted: Linda Powers at Phacilitate, 1/23/19 at 11:30 amAgenda
This is it in a nutshell: Greedy billionaires who just can't get enough trash a company and thereby deprive dying patients life. Utterly despicable.
Being that he tumors in this case are external, the pseudoprogression, and later regression, is obvious and quite graphic.
I would not be surprised if we learn that the MRI adjudication process was forgone in light of known blended OS.
Meirluc, Linda is not prolonging the trial. As she said in the 11/19 PR:
And while each of the processes may be a multi-month ordeal, the first three of them could run concurrently with the validation process just trailing the collection process. So, although multi-month, nothing's to say they don't largely overlap, because, as you point out, much of that work has been ongoing. It's only the latest data that have to be collected and validated. Everything is beginning to line up very nicely. And, it won't be 2020 as some have claimed. The end is nigh.
Good job following the footnotes. You may be the first person to compare the 30% they claim to the numbers Reardon got.
Access to the full article requires purchase, and it's not on my gift list, yet.
One of the comments that started to stir my tired, lazy imagination was this:
Pseudoprogression in current Lancet:https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30654-5/fulltext" rel="nofollow" target="_blank" >https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30654-5/fulltext[tag]Pseudoprogression: fact or wishful thinking in neuro-oncology?
David A Reardon
Michael Weller
Published:December, 2018DOI:https://doi.org/10.1016/S1470-2045(18)30654-5
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From the abstract, if you're unable to access-