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While the presentation At ASCO didn’t have the registered Trademark when referring to DCVax®-L, the press release announcing and link these presentations does. That is called Branded marketing.
At the meeting, the intended audience and feel of the presentation was scientific. You don’t use branded, registered trademark in scientific discourse.
They have a small and very loyal group of shareholders that are holding out. Maybe a few weak hands that are not long investors. They are holding out for an unambiguous end to this story which will result in a short squeeze never seen before due to the ‘hundreds of millions of illegal, naked short shares.’ Those are LGs words quoted, not mine. I used a single mark instead of two because it may be slightly paraphrased.
What advantage do they get from disclosing? Phenomenal data was met with a 70% decline in share price. Updating Clinicaltrials in US, and thus finally speaking for FDA, with only the two endpoints that are a priori after the analysis was met with no gain. That analysis was performed more than a year ago, but the SAP was not rejected by FDA as Dr. Linda Liau had communicated earlier this year. FDA ‘approves’ a final product, otherwise they don’t reject which is not the same. You cannot speak for FDA without their permission to do so.
After you are approved to market, you submit your marketing materials to DDMAC or the biologic equivalent. If they don’t like them, they have 30 days to reject or comment. When neither of those occur, you are ‘approved’ to continue using them. But as most everything FDA, they reserve the right to change that status at any time immediately and sometimes do, same thing pre-approval. They only approve a product for sale & marketing. Everything else for the most part is not rejected.
Ask yourself, what changed that allowed them to feel safe speaking for FDA and why post only 2 of 6 endpoints? You can’t speak for FDA.
PS - If you call yourself a drug and not a food supplement, you cannot market a branded product without FDA permission or approval. People like to bash me, but they started to market a Branded product at ABTA.
The regulation actually says that FDA cannot disclose an application without approval from the company.
I think Linda Powers is well within her right mind and has submitted an application many months ago. Do you honestly believe no UK application has been submitted either?
Strange the things people believe these days.
The second of two Validations engineers is still listed at Cognate. You know Validation is a post-marketing role? You don’t validate experimental processes as they are still in development. You validate approved processes.
The 3 Flow Cytometry specialist jobs that have been listed, have been filled. So many of the jobs listed have been post-marketing positions.
I have worked within Industry manufacturing as both a QA chemist and Validations specialist, (as well as a few other departments outside manufacturing). Those early roles are how I paid for graduate education and training.
I mean Cognate. I continue to go to CRLs career page and search Memphis, TN.
In Chicago, there is a building called WIllis Tower, but locals call it Sears Tower. It will always be Sears Tower to locals. Call it Charles Rivers Labs, but that facility is Cognate to me.
I mean Cognate. I continue to go to CRLs career page and search Memphis, TN.
In Chicago, there is a building called WIllis Tower, but locals call it Sears Tower. It will always be Sears Tower so long
One of the Cognate jobs I tweeted a week and a half ago was for a Technology transfer person related to new equipment technology. Another was for a Calibration specialist. I believe both have been filled, but I haven’t gone back to check.
Around 95 total jobs posted this year about 3 weeks ago was closer to 75 with about 40 still open. Now only 18 of 95 are left open.
DI indicated to me that it has been submitted and implied that publication is pending soon.
ChiU, don’t sell yourself short. My skill is putting puzzle pieces together into a story called analysis, but you took the batton much further, added new insights and backed it all up with factual references.
Together we have formed quite an alliance over the past year or so. May it continue well beyond our hitting pay dirt. Perhaps it will be the Annual Shareholder meeting, perhaps a tropical destination, but us long and hardy supporters of the truth need to plan to meet up and congratulate each other.. Retail gets sold short often. We establish momentum and have swallowed up a heck of a lot of ill intent.
In the words of the immortal Bono Vox, we have broken round this foolishness, they could have left many hearts black and blue, but instead together we have magnified Magnificence, Magnificence.
Our Linda’s may not have made this happen without us, left overwhelmed by naked advance.
Well done Swegen!
Wonderful summary with supporting links. Itook the liberty of Tweeting this out too. Thank you, ChiU
Eaten like Soup, man
Thanks for sharing Xoma, good to see you back.
For those keeping score that’s over 2 million shares. Just who is selling 2 million actual shares at or below 70 cents? Any longs willing to give up those shares for modest gains or even a loss, knowing what we know?
I didn’t think so
Thank you Zadie. I only lurk here occasionally now as it is hard to tolerate what gets said and tagged and remains in play though patently false and often defaming of individuals versus what is considered out of bounds.
Poorman, psychological warfare is very difficult to endure and has broken down the most disciplined, trained fighters. The purpose is to create doubt and fear, doubt in oneself, doubt in others, and a complete loss of faith.
We have seen great data presented by two world leading experts and endorsed by the Magnificent Dr. Linda Liau. We have seen a manufacturing plan that is robust and highly intricate, protected and classified. We have seen an immense patent protection and market exclusivity plan. We have seen support from experts who practice at renowned institutions. We have seen tens of millions of shares change hands since early May, and yet the price has been dropped 70% and contained there.
Don’t break. You have support and our thesis just keeps getting proven correct. There is a purpose to the psychology and there are cracks in our ranks.
Yep, try2.
Wise words Umibe
Just because I no longer post much doesn’t mean I don’t stand firmly behind Dr. Liau and her worldwide team of expert clinicians and scientists, Linda Powers and her tiny little crew of superstars, or the remaining combatants that continue to counter strike all of the BS that gets posted.
Patience is a virtue. Stay strong and keep the faith.
Why boast at thyself, oh evil men
Playing smart and yet not being clever
If you are a big, big tree,
We are the small axe
Sharp and ready
Whosoever diggeth the pit,
Shall fall in it
And whosoever diggeth the pit,
Shall bury in it
Because if you are the big tree
We are the small axe
Biosect, I have always appreciated your insights, but sadly rarely read anymore. Just not worth my time. Twitter is where I reside
Thanks, Nic. I replied to you on Twitter last night… where you will now find me bc the Soup can’t remove the meat.
Sunday morning meditations, I share with you.
Whose to say what’s impossible well they forgot
This world keeps spinning and with each new day
I can feel the change in every way…
And as my mind begins to spread its wings
There is no stopping Linda’s curiosity
June 4th is gonna turn this whole thing Upside down
I find the things they say just can’t be found
I’ll share this love I found with everyone
We’ll sing and dance to Mother Nature’s song
Illinois law allows you to record voice without consent of the recorded party, only if you also have image. Your plan must be careful to have video with voice which it sounds like you will do. Hopefully others will follow suit.
I don’t know why everyone claims drug approvals come on Monday. Most that I have worked on were announced on Friday. Boy wouldn’t that make for a long weekend.
Maybe some after hours news today? Boy wouldn’t that make some people sweat this long weekend out.
So will FDA and it will be a Bigger surprise in a gargantuan market.
LP continues to give true longs the gift of cheap counterfeit shares, and all I hear is complaints. I wish I could back up the truck right now but I’ve got a partner and that matters to me.
No problem Chiu. My mission is to inject light into this sea of darkness and despair because that is all an illusion. Just because LP put up a veil, which is now very thin doesn’t mean developments are not ongoing. Just look at Flaskworks and Sawston. We have good chance that FLASHWORKS will be approved for manufacturing in a flash. The whole Sawston deal itself is part of the UK regulatory process. Why do people think LP can only work one pathway at a time? The woman has proven her genius to me over and over and over and over and over again.
She has been playing 4D chess against some 1D champions and they think they have won.
I can’t wait to see Marnix and her drop the mic
As I recall the KM graph without looking at it, there were 7 LTFU censors based on there placement on the graph, and 5 - 6 that had not yet reached 3 years. One mark was difficult to discern if it represented 1 or 2 patients. This makes absolute sense because the data was shown in mid-Novemeber so it had to be compiled at least one month earlier and we know the final enrolled patients were enrolled in November 2015.
From the data presented, it can be mathematically shown that the 231 OS was triggered in Aug 2018 +/- 2 months. I can go back and find my posts on this subject if necessary. The shortly after presented updated data that was necessary to make these calculations at SNO 2018 and announced that they were moving towards data lock. We now know that they rebuilt study design and SAP and sought the approval of all four regulators before locking almost 2 years later. This process obviously took time to gather and build an ECA model that was acceptable as well.
I hope this helps, flipper.
Look at the rodeo clowns as entertainment and consider LP cares 1) About making sure DCVax comes to fruition and realizes its full potential, 2) LP and husband are billionaires with deep ties and didn’t need all this hadtle to turn a buck, 3) DOJ is the prosecution arm and don’t open criminal investigations without substantial evidence of wrong doing, 4) why not PR all thses awesome developments, 5) LP and LG do care about long term investors but not swing traders. That is why they have told us and foreshadowed everything. Believers believe. 6) Often it takes a sting operation to gather everything that you need. 7) FUDstein has gone off the rails bonkers recently and STAT’news’ is now blocking everyone too.
Tick tock, tick tock goes many clocks, tick tock
Here, here!! Anger should be at price containers/shorts as well as SEC for their poor regulation of illegal shorting and laughable penalties is caught. Will congress ever act against people that spend so much on elections?
Americans need to consider using the populist Amendment to the constitution pathway by 38 states agreeing to pass laws directed at a constitutional amendment to ban all shorting. This is how we lifted the prohibition on alcohol.
PUTS and CALLS still let you play both sides of the market, but do not create counterfeit shares. Temporary synthetic shares maybe, counterfeiting not. Why is it criminally illegal to counterfeit the greenback, or bank check, or bonds, but not stocks? Naked shorting and general shorting, kills American innovation which produces high paying jobs at home, and destroys American savings both individually, institutional and pension fund.
My friends told me that no one could understand my tweets as I struggle with word limits. So apologies for the redundancy here. An analysis of recent development.
1) company states and it is actually required if one wants to file in a jurisdiction, that the SAP would be shopped by all 4 RAs and approved before datalock. Time between the anoincement that they are ready to proceed towards loch (11/2018) to lock (10/5/2020) suggests negotiations were required.
2) data lock happened on 10/5/2020
3) shortly after the RAs from UK and EMA post new study design and endpoints on their clinical trial sites indicating they have approved new design
4) US does not because it is the company’s responsibility to update clinical trials site, but they don’t and shorts bash saying they didn’t get US buy in. A few months back, however, Dr. LindaLiau confirms it was submitted and not rejected by FDA. This is how they do things until actual drug approval. Even an SPA is non-binding. So, since companies can’t speak for FDA and not rejecting is not quite the same as approving, NWBO doesn’t update the site.
5) LL presents database and study design with new SAP at Mt. Sinai in May 19, 2021. This demonstrates the company has alll elements to submit the BLA (did they? … 12 months tick tock)
6) late August 2021 company begins a premarket promotion campaign at ABTA, continues with hardly undbranded advertisement in October magazine, and then has the infamous Tote bag at SNO in November. Booths are pulled from these meetings. (Did this start the accelerated BLA acceptance, add 6 months and one 3 months no cause extension and you get end of May, but I like the first option better as it adds more flexibility to timeline plus or minus 2 months, although FDA can issue another extension to buy more time if needed)
7) NYAS presents TLD, but no PR…why is that? Is it part of a short trap as promised with accompanying FBi sting operation? Sure suspicious that great data drops shareprice 70%. On 70+ million shares traded.
8) they speak for the FDA and post new design & first 2 endpoints on clinical trials.gov. What changed? Why are they now comfortable speaking for FDA? Also, price does not climb despite this confirmation & whacking of primary short thesis. (I believe this is proof that FDA returned the “red-lined label after up to 30 days” following NWBO submission of final step “draft label” if they are will to accept FDA changes with minor language tweeks…the deal is done.
9) No PR… see also 7
10) clintrials only has 2 endpoints, why? Well, this is different than EU because the non-binding agreement with FDA previously, switched to binding after the data was agreed upon (and now presented). The third endpoint missed (curious they ordered the least likely endpoint 3rd… probably an FDA requirement to give FDA more flexibility about 4, 5, and 6.
11) This proves that the endpoints were ordered to preserve alpha and keep hurdle at p=0.05. After the analysis now 4, 5, and 6 are post hos but not necessarily excluded from the label. Dealers choice not companies. This also indirectly proves #10.
12) Is this an FBI sting operation? How to catch criminals?
13) APPROVALS are PENDING … who is on first? What is on second? Does is third really mean all four at once? No PR YET!!!
14) ASCO product theater is on opening day of the industry/scientific congress and NWBO gets access to the media room. What is going to be said.
15) Enquiring minds want to know about BLA submissions. I already know
Call d’arms: PLEASE tweet the great Seeking Alpha article. I need to figure out how to do this myself. I have been informed that in order for Seeking Alpha to kick in their own self-promotion of articles they measure tweets. You can’t retweet on Twitter, you need to open an account with SA and share/tweet through their site.
Many here believe we need new investment money to raise the price cap which means we need more media attention. SA is widely read and will promote articles.
Try2, a few new people added bc my enthusiasm leading up to NYAS. In addition to great science, my story always includes the short destruction side as a primer for a squeeze, and I warned that it may continue until pending approvals. I also tell everyone that I am not a financial advisor and you have to make your own investment decisions.
I was briefly worried about the egg until I was told by most every since one of the many, many holding with me that they have the eggin their hands so that they can help build the cake to celebrate the masterpiece at hand.
The argument “this is nothing new, management has been doing this to you for years” should give you all peace and serenity. Yes, she did masterfully keep us in FOMO and holding tight, yes she has dripped information out as breadcrumbs to keep us excited. NYAS and clintrials were NO BREADCRUMBS. They are cold hard facts about the truth of where we stand extactly at this brief moment in time.
THE TIPPING POINT!
I honestly don’t understand those who have had gonads of titanium for 3, 5, 7, or 9+ years like me only to waver and sell now. FORTITUDE my friends. KEEP IT, IT HAS BEEN YOUR STRENGTH
The boulder that this management team of 20 people lifted makes Atlas look like a wimp. LP had the future of human life on her shoulders and got er done.
I agree we need to replace management… with more clones of management. Imagine what 3 Linda Powers and 3 Shashi Murthy’s could accomplish in the next 18 months.
I am being paid to do your research for you? No
It is not hard to find a group of recently approved first drugs for companies and look backwards. It’s not hard to biotechs in clinical development stages. But since, I am a nice guy, I’ll throw some at you from top of mind
CRSP, NTLA - earlier stage good pipeline in promising new science
My last engagement with you before placing you on Ignore this Member. It is a great feature others should learn to use.
You seem to ignore what stares you right in the GD face. And then you post it as evidence of your righteousness.
“I guess being on OTC with a xxxx of price containers has its impact,… $4 is what the minimum SHOULD be before the first of those two gets revealed. “
The truth has been revealed by Dr. LL multiple times and most recently regarding FDA process. The truth has been revealed by Dr. Mulholland at NYAS and yet the stock price dropped before, during and afterwards. The truth about FDA has been revealed by LP on clintrials, but the price remains capped. Neurooncologists across the globe are lining up to support these results, and then get blocked on Twitter.
You attempt to discredit me, but the truth has been revealed by me.
“Good day to you sir. I said GOOD DAY!”
Ping pong ping pong, short long short long.
Criticism is not analysis. Criticism does not take much effort. Putting one into the outfield during batting practice demonstrates nothing in reality.
How you interpret my remarks and my intent is on you, brah. If you read me, I am willing to throw my personal analysis out for others to read. If you don’t like it fine. If I make a mistake, I usually correct it once I understand that it is a mistake. My intent was not malicious. In this case, I did not make a mistake but you felt the need to come out of NOWHERE to attempt to rub my face in the mud.
This stock SHOULD be trading at nothing less than $4 relative to peers at a similar stage of development, but actually a lot more, BUT it is not.
Is that clear enough for you, brah? Is that should carrying too a heavy load for you as well? Do you care to continue this game? To you care to have me analyze and critique your every word? Because I can and will for a period of time if you want to keep this little charade going.
I can see your intent quite clearly. It was not at all obfuscated. You have no capital with me. Insincere apology not accepted.
Why are you trying to engage me in a somewhat friendly way now? I am always willing to walk away or not.
People who build capital with me get leeway, people who have not, do not. I too have offended and been offended by others whom I wished to rebuild with afterwards. I will defend those who are somewhat defenseless even when it is not my fight. That is because I have been bullied, but never beaten by a bully. That can rub some people wrong. I am generally peaceful but can get cross when wrongfully crossed. I have learned to trust that a sharp mind will generally defeat any size of braun. But that is not the only secret to my power. In my life I have been wrong and wronged, and recently stabbed in the back. Unlike Caesar, I have stumbled but no one has ever been able to take me down. Not ever before, and not now either. Underestimating me generally leads to ones demise. So many people have underestimated me my whole life, now is no different.
If one comes from left field with pious hypocrisy, I can be downright nasty. In most cases, I and others with whom I have offended make peace.
You, who the heck are you?
Thanks for the complement Crash!
Collectively we are all having and have had an impact. Why block everyone?