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It has me more than a little worried! When billions upon billions are at stake, people will even threaten the great and wonderful Dr. Linda Liau.
Diddo! She is a heartfelt, reputable person. Haven’t people yet learned to believe the unbelievable when it comes to NWBO and those that swirl around it.
See attached link. It is not clear to me that the EMA equivalent is deemed acceptable and regardless the discrepancy between the two registries was problematic. DI does not always speak with full knowledge based on reporting I have read here. My phone interaction with him led me to deem speaking with him useless not because of him personally but because he plays his role well.
https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
Thanks for this clarity Dr. B!
Not sure what the question marks represent AP but I believe that everything has, is and will unfold according to plans that they have shared with investors. Smokescreens, FOMO, and other skullduggery has been employed in an effort to save the company, save DCVax, and catch nefarious actors in the act. My constant belief in the plan and LP has allowed me to act when others have been afraid.
Doc, also not a bad theory IMO. It is certainly not abad sign if that is the spin.
This is also a good time to remind those here that the results seen upon presentation at NYAS are an ADJUSTED comparison and that one of EXwan’s favorite criticism of the ECA database was that DCVax trial had a slightly less severe population as well as the comparisons made before NYAS were not apples to apples since DCVax data was from surgery where as the database was from randomization, thus favoring DCVax. The ADJUSTMENT fixed the imbalance by reducing DCVax raw data and the comparison to randomization now flips the favor towards placebo bc many of the patients in the ECA were randomized at 6 weeks vs 3.1 mo. Finally, the 3% IDH mutant rate in the DCVax trial is very low and likely much less than the unknown rate among the ECA and therefore also reduced true efficacy analysis.
Conclusion, the analysis is extremely conservative favoring ECA and FDA will or if you align with me HAS understood this in their evaluation of the data. It is not far fetched to believe FDA continues to show flexibility regarding the 11/22 speculation.
Basparks, That is a very good question for which I can only speculate. Obviously, the database was locked in October 2020 and thus the study as we understand it today is complete already. Companies can and do continue to follow patients and given that survival in the 4 participating countries can be tracked by public records of death with investigative accounting for gaps, perhaps the FDA is allowing for an additional analysis of the 7 year survival tail which concludes with all patients in Nov 22. While this is historically considered a post approval commitment or phase 4 design, perhaps it was prespecified in the approved SAP and may be helpful in demonstrating efficacy in the originally randomized cohorts. Cross-overs did well which confounds the original analysis of OS but not that well that you wouldn’t see separation over the long term.
Or perhaps, it is wiggle room or smoke screen to continue to provide the other side to criticize and question.
Yep, you actually cannot publish without a synchronized Clinicaltrials.gov post…check one.
You can’t speak for FDA unless green lit to do so… check two.
You can’t premarket promote unless green lit to do so… check three.
Often, you can’t catch criminals without a sting operation… check four.
All those sour grapes can’t see the service LP provided to humanity. Cement DCVax as standard of Care. Guarantee manufacturing capacity for GBM and beyond. Protect your assets with patents. Then, bring down those that wreak havoc on American savings and biotech innovation.
Linda Powers is a heroine to us and to humanity. She saved Dr. Liau’s and Dr. Prins’ creation from the pits of despair.
I Thank Linda Powers deeply for taking us through this wild ride and allowing me and mine to accumulate a huge number of shares. She changed the trajectory of my family for generations to come. People should appreciate the course she took at every turn, especially manufacturing and squeezing. I have to post it again because she didn’t have to love me like she did, but she did, and we did. AND I THANK HER
Maybe now whining, complaining and dragging Lindas names through the mud will end, but I doubt it.
When I am soon vindicated, my critics can suck wind
BOOM SHAKA LAKA BOOM!!!
Victory declared. See this updated posting and see my tweets from last night
https://clinicaltrials.gov/ct2/show/NCT00045968?term=Dcvax&cond=Glioblastoma&draw=2&rank=3
One Golden Rule in this industry… Never Speak Publicly for FDA.
Agree, any expectation for them to do so is misguided
Changing the Clintrials posting at this time tells you everything you need to know. The SAP needed to be submitted and accepted prior to data lock. LL confirmed that FDA ‘accepted’ this in their typical manner by not rejecting it within 30 days. This does not allow them to change the posting and speak for FDA without definitive permission to do so.
Ask yourself what has changed? There is another 30 day timeline that matters right here, right now despite JMJJs criticism of my views.
The attack on this company sure looks coordinated to me and there are a few public voices that create false narratives with suspicious timing. Let the DOJ do their work before casting final judgement here.
I believe the NWBO PR indicating Cofer Black was hired to investigate illegal naked shorting in this stock, and LG when he a couple years afterwards stated that there are 100s of Millions of illegal naked shorts. I also believe Bigger had specific knowledge when he more tha alluded to the idea that NWBO was involved with the DOJ investigation. It sure seems to me like every piece of positive news since 2015 was met with intense selling. Just where did those shares come from and who was involved?
Inquiring minds want to know. I want to know.
That’s rich JMacJJ. Suddenly you show up, start posting here, criticize me and are now anti-AF and interested in defending the truth.
Now I get it!
Thanks Bright Boy, Please Stress the fact that spreading erroneous information about an effective product is detrimental to patients as it may discourage them from taking a potentially life saving therapy. As well, if either of them are ‘on the payroll’ recently of The helmet, then we and or NWBO can file a complaint once DCVAX is approved, if not redacted, with FDA and OIG as they are then ‘agents of the company.’ Misbranding a competitive product is a violation of one of the ‘golden rules’ and carries the potential for personal liability. Soon we and or LP will have enough money to make their lives difficult.
Linda and Linda serve a red hot dish to humanity and all people do is criticize. LP serve up a dish with special sauce if you believe in her and have the gonads to stand by her side.
To my good friend who does not like my taste in music but is an avid reader…
Sorry brother, but as you can probably already tell, I hear my inspiration in music! How can anyone hate Journey?
That’s okay. I will still buy you that parking spot and share a meal or two with you. Hopefully, Jack Johnson, G Love, U2 or Red Hot Chili Peppers will be allowed as we drink and party!
Who doesn’t love noodles?
I joined the Twits and am looking for followers. It is open source.
If they didn’t submit until AFTER NYAS, then the 10 Business day expectation hasn’t yet hit. Besides everyone everywhere uses COVID as an excuse, sometimes it is true. COVID has put half my workforce including me down within the past month.
Twitter BOMBSHELL just dropped Dendreamers!
Don’t stop believing, hold on to your Dendreams!
Delight in the short squeeze people.
Don’t stop BELIEVING!
Well, Whitewater since I have actually paid attention to official communication by the company in the past, as well as unofficial communication with trusted sources here, and have communicated directly with Dr. Linda Liau myself, I have complete faith in this process. The process and expectations to me are laying out exactly according to expectations and plans.
Most longs, before data release knew and expressed a belief that short interest influencers would attack the data and disparage the process (BTW that is the correct use of the word disparage). Suddenly, after that happened it is the company’s fault. Responding to these critics only drew more attention and dropped share price further in the past. So, the plan was to let the data and the experts speak for you as well as release multiple positive pieces of information in close proximity. The company has put a stake in the ground on June 4th at ASCO, has indicated that they have submitted for clintrials update and in my next Twitter post, I will add one more element that people here and there don’t seem to grasp.
Believe in Linda Liau, I have stated this over and over. Believe that Linda Powers knows what she is doing. Her ability to keep us afloat, make amazing progress on the patent front, turn the tables on the critics regarding manufactwhich is now totally in Our control due to FLASHWORKS aka Flaskworks, add regulatory and uplisting expertise through both organic and consultant additions to the team, have a global strategy that puts pressure on FDA, etc. etc.
What’s good for the goose is also good for the gander.
Have a beautiful day
Administrator please remove this post. While not directly name calling this is disparaging to me and thus against your rules which is regularly enforced upon me.
I wish everyone could see NYAS as it was. That was the sound of the cleansing, anti-infective, everlasting Sound of Sunshine coming down the pike…
Yes, Senti broke this news on Friday. My only complaint here is that they could have submitted the request a few days earlier so that we didn’t have to wait it out so long after NYAS, but perhaps this is all part of the greater plan. Hey Oh… Everyone has one last chance to load up before the crescendo. NYAS was just the foreshadow of the penultimate defeat of the other side. Every good action movie has a battle before the Mano a Mano scene which is not the ending just the big reveal (aka, journal publication).
We will have our day in the sunlight of ASCO’s Industry Sponsored Theater for certain on June 4th just 2.5 weeks away, and likely in a reputable journal beforehand. The updated posting on clinicaltrials.gov will add credibility to both.
The game is afoot despite strange things happening at the Circle K presently. Stranger things are happening throughout the small Biotech sector and I am hopeful that the DOJ will also sort things out to remove the bad actors who destroy America’s future and global dominance of this critical export industry.
Lives, high paying jobs, retirement plans, public pensions all suffer at the hands of unscrupulous divesting in American technology.
So only 7 IDH + mutants in DCVax(R), but an unknown number in the external control arm. Another reason why the NWBO analysis was very conservative and underestimated the true efficacy of DCVax(R).
FDA is reasonable and will see that this drug not only works but more importantly is extremely safe to use. They will NOT deny suffering GBM patients their chance at life.
Doc,I personally don’t care what the price is tomorrow or even after their publication comes out very soon but after clintrials.gov gets updated. I expect AF, FUDWest Hedgie, AACR and the lot to continue this misrepresentation all the way to the pending approvals. Then, they will be destroyed by LP and her team.
Not sure if this has been posted yet. There are 17 new jobs posted at Cognate in the last 10 days. Some interesting stuff such as:
Director Global Trade Compliance
A few more Manufacturing Mangr/Supervisor
Warehouse manager
https://jobs.criver.com/search/?q=&locationsearch=Memphis%2C+tn&searchby=location&d=10
You stopped before SHOULD which connotes that it likely may not. It does not say WILL.
ACT has in addition to similar math and english section, science and social studies which are less about knowledge and more about comprehension of the readings provided.
Awesome work and critical intel, Senti! Thank you for clarifying the misinformation being spread by many and in particular YOU KNOW WHO YOU ARE.
johnnyMacJJ, I think you gave a reading comprehension problem. Did you ever take the ACT and what were your scores outside of Mathematics?
Thanks, Doc. I appreciate the direction. I can’t keep everything straight as I am pulled in so many directions right now. I am splitting what little time I have between here and Twiiter. This place is my first love but I have to admit that the censorship has really turned me off.
Well, I don’t agree at all with your premise. They said they are under short attack and know that there are 100s millions naked shorts. They said they would roll out successive information because of the shorts. We knew the data was not enough and AF and colleagues would immediately lie and attack. We even were prescient and indicated exactly what their attack would be and has been.
Now we await the succession. Weak hands crumbled. I don’t think they have sympathy for weak hands, I personally don’t have much myself. Most everyone I know held tight but some faultered. I am sorry that they did, but weak hands none-the-less responding to reptilian brain rather than Homo Sapien Sapien brian.
Joan Lapis and Smith on Stocks showed their fortitude and I contniue to show mine
Weak hands will be weak hands
FDA is behind EMA in this regard. FDA efficacy then safety, EMA safety, then efficacy
OMG did not know this Cherrytree. thank you
DocL, Just to add, a universally fatal orphan disease where the treatment in question has no adverse effects.
As a source of relative reference please look at the Exondys 51 and note the lack of efficacy and failed trials along with a paucity of safety experience.
https://www.exondys51.com/modules/exondys/files/EXONDYS51PI.pdf
It sells for about $450k per annum if not mistaken and it does sell.
My view…UNDOUBTEDLY and it has already been submitted.
Why can’t people trust the plan they laid out. They and we knew this would happen and that it would further trap shorts. The crescendo is building, it hasn’t happened yet.
$2.50 lets them off the hook way too easily. Think like a BIG GAME fisherman and fight like hell for your prize catch!
I saw it with Tysabri and I saw it with Exondys 51. Physicians fight for their patients, not for the stock or really even the drug, on behalf of the drug but not for the drug. FOR THEIR PATIENTS.
FDA listened in both those cases.