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Merry Christmas to all.
“Often some want to believe what they want to believe. “. I’d suggest ‘generally’ instead of’ often’.
Nice assessment of the prior post, thanks.
Dr. Bala - À votre santé!
Connect the dots
Remember, had the poster been presented at SITC, the same would hold. Instead, I believe they're using the accepted abstract only to publish in JITC.
And, this next bit isn't directed at you, Flip, but I'm not going to waste a separate post on it. For those enlightened posters who think that there can't be a PR prior to a Journal publication, read the Smith on Stocks. I'm not going to waste time on it. I offered what I gleaned from my talk with DI last week as information for the board. Reminds me why I haven't bothered sharing for a year.
Thanks for your keen insights. Always admire them.
Comments made by DI in a conversation we had last week are pretty much echoed in Larry Smith’s 11/6 piece:
.”It would be a colossal mistake to release the data in a press release. It should be released in a peer reviewed journal or a medical conference. It could be the case that the Company is in discussions with one or more journals or conferences to release the full data set. If so, the Company must walk a tight line on what it can put out in a press release. Prestigious conferences and journals will not present or publish results of a trial if the key findings of the trial have been previously released.” DI also commented, as Larry does elsewhere in his piece, that they are not going to release the results of a 14 year, $600mm trial in a poster or a ten-minute talk. He stressed the value of a journal publication as they move into the next step with regulators.
JITC publishes articles within 2-4 weeks of acceptance.
Spoke to UA. They’re recording the presentation and will make it available. They didn’t expect the response they’ be gotten.
Zoom room is full. Can’t sign in
The company never issued a PR regarding the upcoming presentations at SNO or SITC. These were board discoveries. Why does everyone feel it's incumbent upon the company to explain why the abstracts were withdrawn? People criticize the company for failing to meet their self-proclaimed deadlines. In this case, I believe that they knew better and, therefor, didn't risk doing PRs for the upcoming conferences.
If anyone is strung out and needs a dose of Linda Liau, tune in to her hour long talk this afternoon at the U of Alabama. See whether she's smiling.
Pick up the phone. You have the power to.
Look back and see how many R/S there were for CVM.
4:00PM CST is correct.
Linda Liau will give her one hour presentation this Friday, 11/6 at UAB. It's hard for me to imagine her speaking for an hour and, very likely knowing TLD, not speaking of it or alluding to it somehow.
Senti- Home run! Thanks!!
Iwasadiver: The DejaVu topic is near and dear. You'd also probably find this discussion I attended at The NY Academy of Sciences a while back of interest. I think it should be accessible to non-members as well, or maybe you are a member: https://livestream.com/newyorkacademyofsciences/reality2018-3/videos/187005735
Iwasadiver: Love this post. Two things come to mind that might interest you. The first is an article in the current issue of Nature (15 Oct.) on how the brain's immune cells (Microglia) put the brakes on activated neurons. Previously, an unknown function of the immune cell.
The story of starlight falling on the backyard experiment reminded me of the second item. The circumstances in the following article seem weird, and they are. But, I personally have been to this lab a few times, know Bevacqua, and seen the process in action. Not a pump for this item, but just saying that this account is pretty much how it all went down -- Huber Sounds like witchcraft, I know.
The universe is not made of distinct and separate parts. Everything is integrated. Take a 'simple' example of the moon and the tides. So, I agree with your point of creating molecules foreign to the body and placing them in a specific target to perform an intended function may lead to extremely unanticipated effects.
Iwasadiver - Enjoy the break. I'm looking forward to a two hour dental procedure later today during which I won't be able to check the price. Rinse, spit, repeat.
Whitewater: What, Me Worry? (Those who know, know.)
Great post and incredible patience.
I've sent NICE an email inquiring whether they've been updated by the company as to when to expect a response from NW regarding timeline and when to resume the evaluation. They said they're extremely overwhelmed but hope to get back to me in 8 - 13 days.
Best of luck.
I've been astounded by seeing a lot of poster's projections of pps at various junctures. First off, I was here when pps hit 12.55. The share count was about 100M, not 1.4B. So, don't tell me pps will return to its previous high.. Retail will not drive the price, IMO. And, pros will know better about what a reasonable MC estimate would be. My strategy at this point is to remain somewhat 'organic' to developments as far as an exit strategy. I'm considering a trailing stop loss leading to top-line.
Yes, nice thought. But, come on!
You analyst friend's scenario sounds intriguing, but how would Merck come up with a billion+ shares for a one for one? Am I missing something?
I believe you're citing the rule to REMAIN listed. Not the initial listing requirements.
Oh please. give it up already. Your learning curve flat lined a long time ago.
Thought I'd check in on the NICE site in the UK as I do from time to time. I came across something I hadn't seen before there.Consultation comments on the draft remit and draft scope for the technology appraisal of DCVax-L for treating newly diagnosed glioblastoma multiforme
Issue date: June 2018. NICE is the National Institute for Health and Care Excellence. Many will recall DCVax was up for review back in Sept 2018, and was suspended until final data were available.
In the review process, NICE consults with various experts and concerned parties for input in creating their guidelines for the new treatment. The last section of questions the consultees and commentators address basically asks, "Did we overlook anything?" The Association of British Neurologists suggested this:
Are there any subgroups of people in whom DCVax-L is expected to be
more clinically effective and cost effective or other groups that should be examined separately and how are they identified in clinical practice?
Should patients with a methylated MGMT gene promoter or mutations in
the IHD genes be considered as a separate subgroup?
Given the current lack of phase III studies on this this question can not currently be addressed.
I think this offers a slight bit of insight into their thinking and definitely bodes well for DCVax.
LG's statement on the Big Biz 'show' on 9/23 was (paraphrase) 'we are nearing data lock'. This is recorded and will be easy to fact check when the actual timeline is known. I highly disagree that Les would out and out lie in a situation like that. I stick with my previously stated hypothesis that after soft lock, something needed clarification and the CRO had to get back to the site(s) for that. It just took some time. Yes, I know they had already locked down the sites. However, there could have been an issue with the manner in which the data were reported/delivered from a site that had to be corrected.
indeed!!!
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.