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If true, maybe Ashkans will be speaking at industry expert theater.
Are they allowed to present that type of info at industry expert theater?
All this "good news" and still no buying. I am worried we don't see anything prior to, or at ASCO. Stock will be back in the .30's if that happens, IMO.
And yet we sit at .69
bollocks.
Nonsense. It was irresponsible, at a minimum, to allow ANY presentation of partial data prior to the full TLD/Journal "plan" they have been touting for 20 months. They had to have given the presenters the data, as it was part of the unblinded final results. Why? A lot of LP's strategy was to avoid the potential for shorts to use the results against us. Meaning, we are sticking to the plan that our outside advisors, SAB, etc., etc., told us was the best course of action. We will stay in a quiet period until we can release TLD AND a Journal close together. Massive mistake, reportable change from company guidance to shareholders, and a huge loss in market cap.
Yup. This mgmt team screwed up, period. NYAS was a disaster in planning and execution. If you cannot recognize (or comment on) that, irrespective of the promise of the potential of the DCvax treatment, we find ourselves on a slippery slope of the "board of misinformation."
Agreed. That's why I also will sell a significant portion of my shares by next Thursday if no TLD or Journal. Fool me 37 times with NWBO, not again.
Two weeks have past and still no explanation from the company on the NYC debacle? Why did they do it if there wasn't anything to follow (TLD/Journal), or if that was not the end of the quiet period so they would defend themselves? Why, after 19 months would they allow anyone to present a limited presentation on new data without TLD and full read out? ZERO explanation and still at .69.
I understand you are intentionally being cryptic. In what capacity are you "cleared to speak with an agent of the company after June 9th" referring to? From an investment standpoint? Post quiet period? NDA, non-public info? Are you implying they will be able to offer information we currently do not know, like post-TLD?
There is nothing technical I would look at right now. This is an emotional conviction game right now, IMO. The binary event really hasn't happened. The poor idea of presenting in NY before topline/Journal has spooked the conviction. I believe we will see it come back this week and into ASCO. TLD/Journal prior to ASCO would be the needed catalyst IMO to get us back heading to $1.50-$2.00 until it is digested and explained.
That's a little different than we heard yesterday afternoon. "getting a publication"? Meaning, still looking for one to take the article? Yesterday it sounded like they were bound by a specific Journal. Who F'in knows.
So, does anyone think LL backed out due to the threats and Covid was the cover?
Is Dr. Pazdur the one who is supposed to meet with AF at ASCO? If so, we should collectively email and tweet the same message AEK just sent to STAT news owners!
LOL, true. Probably worth it at this point.
I hope this doesn't fall on deaf ears. There could be a groundswell of exposure and then support for NWBO if the word can get out. Anyone know anyone in the Biden Admin?
Agree with all of your points. This was a self-made disaster. Didn't have to happen.
Ok, that's a much different comment from what I read this morning. From that response I would say 5% chance today. 10% chance next Wed.
0% chance. Didn't DI tell someone yesterday? Journal not tied with last week's presentation or ASCO? That to me means after ASCO....or more appropriately, he doesn't know when. Which, to me, means definitely not today or tomorrow or next week.
I do not believe for a second that anyone in law enforcement of any kind will do anything about this. Look at the Reddit nonsense. They held hearings on Capitol Hill!!
Nothing happened.
To each their own Jim. I have been in this stock for over 7 years now so it's not a "benefit of the doubt" 15 days for me, this is groundhog day.
What world are you living in? They referred us back to the Oct 5th PR for 19 months, which said: "The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.
I never said anything about the ASM or ASCO. They changed their strategy by allowing a presentation during a quiet period and did not PR TLD and there has been no Journal. They changed it, not my narrative. And, I did not recommend anyone sue, simply stated the obvious. There are many law firms who only look for stock price drops and then try to tie back to mgmt missteps. It's done every day.
Here are dozens, just from this morning:
This is extremely disheartening to me. "He did say that the talk, journal article and ASCO were on separate parallel tracks and not necessarily related. The article could come out tomorrow or in weeks, it is not tied to ASCO (my interpretation, ASCO may not be the big moment we are waiting for). Once the journal is out they will be free to talk a lot more. For now they are in damage control mode including getting the fake articles taken down (check) and even corrected."
Separate parallel tracks? That was never discussed or PR'd by company.
-TLD/Journal, that's all we have been told. Quiet period based on getting across THAT finish line.
-After 19 months of silence, they let someone partially reveal the data and that doesn't end the quiet period?
-After years of talking about the naked shorts and cabal, they don't see a massive smash down coming by doing that?
-And, apparently still in a quiet period with no Journal or TLD PR in sight? So, essentially they have not been able to defend themselves?
Awful and potentially open to liability based on fiduciary responsibilities, IMO.
Exactly. The ONLY reason I can think of is Journal embargo. Same reason they haven't defended themselves since the presentation.
We need a 10:30AM PR with proper topline and a 5PM Journal release. That combo is the only thing that will move us higher.
Nope, just getting knocked back under .70 again
I'll take an offer just to pop us over $5 and get some institutional buying and public awareness. But, LP will never sell.
Carlo Rago Tweet:
Today was a good day! Primary outcome declared in the US database as overall survival in ndGBM, secondary outcome declared as overall survival in rGBM. rGBM is a more severe unmet need. Avastin failed primary but was still FDA approved on secondary. $NWBO
Rago retweet:
Gregory Zivic, MD
@metacollectiveG
·
18m
$NWBO Just so sane people are clear; NWBO changed the endpoints in the SAP before data lock. They left the clinical trial site alone until they had data out in public. They informed the public officially of endpoint change in the 2020 end of year 10-K. This distraction is dumb
A strategy and timing update at a MINIMUM. They already F'ed everything up, let us know where we are now.
FDA approval is, in part, based on trial performance based on approved design and whether or not the trial had statistically significant improvements over SOC and a clean safety profile. So, allowing the trial change/updates, including endpoints and ECA comparisons is huge for approval. Not so much for share price.
Don't worry, it will be red by lunch.
Am I correct to assume that the FDA has to approve trial design and updates?
UPDATED TRIAL DESCRIPTION:
The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)
UPDATED OUTCOME MEASURES: No PFS
The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma.
The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM.
No Results posted, just endpoint and trial changes. AND, as usual, NWBO has to stick a fork in their own eye. WHY on earth would you add a completion date of November 2022? Why? Why? Leave it blank FFS.
When you look deeper into the side-by-side "History of changes" section, there is no doubt this took a lot of time and likely had FDA oversight. The changes are dramatic (link below). However, I doubt this does anything for the stock price. We still need TLD, can't believe we still haven't seen it.
https://clinicaltrials.gov/ct2/history/NCT00045968?A=1&B=104&C=Side-by-Side#StudyPageTop
I thought, given the company PR, and reference to the P3 trial, this was a topline presentation and the end of the quiet period...with Journal to follow. However, there has been no TLD PR, no PR from the company since and no Journal. That's why I am so pissed. How many times did they "refer us back to the Oct. 5th PR" which said TLD/Journal. That's why I believe any litigious shareholder may have a case since that is CLEARLY not what happened.
To my point on those selling us out of business. There is very little left on the shelf to sell. And, if the PPS is .08, there is not enough money to raise to stay in business. We already have almost usurious loans outstanding and no revenue to pay them back. Who is going to step in and loan more money today based on the current info on the street? That's why the immediate pivot and offensive strategy is needed yesterday.
Clock is ticking. The goal of the opposing forces is to put the company out of business before anything positive can be fully understood. At a minimum they are trying to take the stock into single digits and make the company look SO toxic, no one will believe anything they, much less post-presentation "changes" that look reactionary. This mgmt and company history are toxic enough.
Disagree. Patience is gone. We need competent adults in the room. This was a terrible strategy from the start. Whoever convinced LP to go into a 19 month quiet period is a moron. BTW, they hired outside consultants, most likely academics (who have never run a business, much less a public company) to recommend a plan.
We need an immediate pivot and an offensive strategy. Clinicaltrials endpoint changes and even a Journal can be lost into the abyss if these negative attacks with no response from the company continue. You only get one chance for a first impression and so far we have egg on our face.
I am still stunned at this debacle. For 19 months, in a quiet period, all they would say is we are preparing for TLD release and publication. Then, there is a "presentation"? that is not TLD? And, with no PR from company stating topline data? And, then, no Journal to follow?
WITF is going on? Then they wonder why the stock got crushed? And, all the enemies and their brothers pile on with no response from the company?
This is impossible.
Here comes the power hour flush again. Another day with NOTHING from the company. It literally unreal.
I think Marzan got strung up by his minions.