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Honestly Stonk, If I Didn’t Live in The Real World, I would be trying to spin this as too good to be true… fortunately it is unbranded. They are not starting to market anything in the here and now.
I mean that list of claims is astounding. Giddy Yup there Linda!
Ok, Big Al says mid March and Stonk say mid February. I recall them trying to stay on time lately so my gut leans toward Stonk, but I do not know these things.
I do know that mid February looks like a clock ticking on one regulator calendar, but COVID could always push that back, I suppose. Mid January is when Dr. Bosch speaks at an industry conference. And all that timing probably lines up to the 6-10 journal review window.
I agree with IkeEsq that you can’t time these things, which is why my FOMO kept me from trading this stock.
ATL, you guys provide the intel and I create equations and draw lines. Your new endpoints bit, put the nail in the short side coffin along time ago. I mean any company can survive on 30-40% of a $3-5 Billion market if they needed to do so.
Sukus - Now, I understand. I only access this site via tablet. I am unable to view it here.
Can you post the exact verbiabe? Sorry for the trouble, but I am quite curious. It is baffling to me that people can’t see what is going on from a Marketing perspective. Consider it a three legged table.
First, despite not presenting any new Congress information for like 2 or 3 years, LL has actually provided a heck of a lot of peer reviewed content at various institutions and CME events. The scientific strategy for statistical analysis, data base construction, and a large volume of actual clinical data inclusive of combo patient cases and no less than 5 actual live responders. Meanwhile, a peer reviewed publication or three gets submitted to a top tier journal.
Next, you have the Unbranded, disease and mechanism of disease work, alongside pipeline forward looking statements in booth and in other venue. Then a shift towards separation of disease materials from other material in space (at congress) and time (full page, quarter page advertisement). The unbranded advertisement lists claims that if directly attributed to a branded product would be efficacy, safety, durability, and a suggestion of approval, but alas it is unbranded.
Then, a Branded campaign of DCVax (R) with only disease and mechanism. No opportunity for contiguous link to Unbranded campaign as booth gets removed from congress. Unbranded remains in IBTA print separated from Branded in ABTA program and at SNO. Where else will Branding be employed? Oh, yea in the updated Franhoufer PR from 2012.
Then comes Mernix. In which bucket does that one fall?
This is becoming from the land of sky blue waters…
Fully Kroisened, from White Mountain Springs and Chippewa Falls.
Here is to good friends, tonight is kind of special!
Sukus, the Unbranded Dendritic Cell Advertisement shows up again this month.
Can you please explain to me what on this green earth people are talking about when they said there are ckaims about tumor escspe and longevity underneath?
I just can’t find anything of that sort anywhere.
How soon do we expect the next 10Q? That could have all sorts of hidden gems within it.
Boy oh’ Boy am I excited for 2022! This $hit is about to GET REAL, and REAL FAST.
DCVax(R) Personalized Dendritic Cellular Immune Therapy for Brain Tumors like the one pictured in the Right Temporal Lobe of the MRI image in the bottom lefthand corner above those claims and below the other ones.
The only shelves that will hold DCVax are in Sawston, UK, Memphis, TN USA, and Leipzig, GER.
Did anyone catch this update to a 9 .5 year old site reference…
DCVax® milestones reached
April 20, 2012
Significant milestones have been reached in the ongoing collaboration between Fraunhofer IZI and Northwest Biotherapeutics (NW Bio) and its contract manufacturer, Cognate BioServices (Cognate).
A four-month long technology transfer of the complex manufacturing process for the autologous cell therapeutic DCVax®-L Drug (Brain) from the USA to Leipzig was successfully completed in close cooperation with project partners Cognate and NW Bio. The extensive documentation required to apply for manufacturing authorisation in accordance with Section 13 of the German Drug Act (AMG) has been submitted to the responsible pharmaceutical supervisory authority, and the nine-month long regulatory process (following the technology transfer process between the parties) has been completed up to the point of the official acceptance inspection. That inspection is the final step which has to be carried out before the manufacturing authorisation can be granted, and is scheduled for June 2012. The completion of the processes to date represent significant milestones toward the conduct of the clinical trial using DCVax-L for brain cancer in Germany.
Here is my new sing along for all to hear if you choose to journey alongside
A repeat of sorts for all y’all. The light that I have followed over 8.5 years has a name and it is Linda Liau. I know very many people very closely who are LL in another time’s forgotten space and in another place. I just follow the leader that I identify as a truthsayer.
No I agree completely with your last statement. My view is endpoint posting plus specials plus MHRA cert = approval
And BTW US Hospitals will charge close to three times that to net at least 50% over cost. Insurance plans will cry and raise premiums accordingly. They and PBMs will split the new profits unless NWBO goes single channel controlled distribution and squeezes PBM out…medical benefit?
Drug company will give away free and discounted drug where necessary and allowed by state and federal law. Meaning, sorry American Scandinavians & Mung people, elderly with gaps in coverage, certain New Englanders, and a few more. Some money will be available through charitable contributions for those people.
They gave you the numbers already. They can treat 4-6 patients from London and 45-50 patients per month from Sawston. They are charging £150k for the full set of therapy. My understanding is that you don’t need to be British to be special so long as their is capacity. A real shame for those well insured Americans who work so hard but cannot spend over $500k all-in when they are dying and their family needs that money.
This is not going to be the global price, but it may be UK pricing going forward. That means most companies would go for about £225k in the biggest market and just shy of that in the second biggest market of people from multinational locations speaking variations of the same tongue. Followed by their Viking brethren at slightly lower pricing once again Australia and Isreal will come to the table with cash and through distributors so will their neighbors. Czechs will pay less than British and Greeks and the other teetering European markets will pay even less.
Mike, Are you aware of the Specials program and what it means?
It means they are already approved once they get the ducks aligned and the Ts crossed. That is what it means. They are already treating patients in a pre-approval state. This is truly a ‘special’ situation for drug products to be in.
Iron Mike, I understand your point and the need to dig in when feeling attacked. I agree that the certification does not guarantee MHRA approval. It is, however, a required step that is necessary for DCVax to be approved.
I also believe that you may be wrong about how broad a license is. My understanding is that the steps of the process are validated and approved. The process used would entail the chemicals added in the exact amount, incubation times and temperatures, the cytokine profiles tested and acceptable range of the output. The stability requirements to prove that the product remains fully active for the duration of the storage. These are all unique to DCVax, maybe not just -L, but not likely a CAR-T product.
- Microbiological, biological and chemical/physical testing of finished medicinal products, i.e. final testing prior to Qualified Person certification for the purposes of batch release;
- Stability testing of finished marketed medicinal products;
- Environmental monitoring and or process simulation (media fill) work for sterile product manufacturer; or
- Biological testing if it is required to be conducted in accordance with the GMP Guide as described in Annex 2 of EU GMP
- Completed any building/refurbishment work relating to the activities to be licensed
- Completed the facility, equipment and process qualification and validation
- Draft procedures and documentation to illustrate how the site envisage the operations and PQS would work in practice in place
How certain are you of this statement?
Pump the brakes on this logic. This certification is in no way, shape, or form tied to DCVAX in that way.
They are allowed to produce DCVax under this cert. This is not a certification specifically to produce DCvax.
I love your conclusion DD.
The signs for much progress are clear and the lack of negative news is quite telling. They have had opportunity after opportunity to give us bad or mixed results, but they just keep their mouths shut which is absolutely making some people anxious. The opposition is in full blown panic mode as far as I can see. Try and try but they just can’t shake very many of our shares loose. Push downward, after push downward and our resolve just seems to strengthen.
Panic and frenzy have already begun, but longs seem steady as Nik Wallenda crossing the volcano.
Flipper, Wow, that is a broad patent. Do the patents in other countries have similar range?
Curing cancer is a noble mission, we all can agree.
Finding the resources, stamina, and perseverance to keep marching on towards the ultimate goal when those hell bent on destroying you, starve you of all reasonable opportunity to garner support, is quite an amazing accomplishment.
Linda and Linda have been remarkably strong leading us through all these challenges. Why are people so callous in the way they communicate about these two women?
Hello, I call that a near miss on the bullseye for Placebo but landing in the 20 slot to close that box. HR (0.91-1.33) is pretty damn close to certainty of being better than PDL-1.
Most would want to take the placebo with those odds, please.
Good morning Fellas and Ladies, are you ready for more of the same noise?
Bah humbug
Coal for Christmas
Where’s the TLD?
Paying herself gobbs of money
Bah humbug!
What I got for Christmas was a warm feeling of calm about my investment knowing that despite stock being pushed down, my ladies got me covered. They gave me a beautiful mountain scene, with majestic pines, and hills that will easily be traversed. They gave me a smart looking tote bag, to carry all of the little candies left along the trail. They gave me patents and certification in hand and pending. They gave me a plan to expand. They gave me a plan to publish, a validated database, an overview of the SAP with its three shots at the primary goal - all of them slam Mother Fing dunks, they gave me a future of research doorways open wide with combos and strategies to keep pushing to the full cure, they gave me some very real ideas of what that 5 year plus data set will look like, and they gave me a New Year in 2022 to be downright excited about.
I hope Poorman is dreaming of his oodles and oodles of noodles he will soon purchase for his hipster food truck.
Ahhh yes, did Sisyphus every get that boulder up the mountain?
Love it! I don’t remember what happens to Atlas, but I assume it is similar to what we know of Godot…the play ends with them waiting, but that doesn’t mean that is where ends the story.
I see myself or you or Flipper, etc, etc with the energy of Linda & Linda & Keymours & UCLA & The Queen, God save the Queen, pushing that boulder over the mountain top.
GDamn! I would not want to be in its path on the other side after that…brother, that is downright frightening..
Boy oh Boy! I can’t wait to see that IDH corrected proportional hazards survival.
Boy oh Boy! I can’t wait to see the comparison of confounded PFS to adjudicated PFS and their correlation coefficients for Overall Survival. That will change GBM study design and hopefully all tumor design forever.
Boy oh Boy! I can’t wait to see Recurrent GBM data, drugs have been approved with less and broad indications are tacit approval.
Boy oh Boy! I can’t wait to see a posting on NWBio.com and FDA.gov.
Jeepers Creepers! I would hate to need shares to cover my rear end.
Someone is going to need to remind me everything claimed in that unBranded advertisement by Northwest Biotherapeutics in their standard green colors with that information about dendritic cell therapies. I really like the hope that gave the patients who also receive and read that circular and I love the messages it gives physicians about the future of their field. I just couldn’t read it all for myself, so I hope some will repeat for me what else was written there.
Otherwise, I am happy with Brain Tumor…DCVax(R)…Personalized…Immune therapy. Followed by call to action and a reinforcement of this call to action directed at 2000 Neurooncology providers during a conference on guess what….Brain Tumors.
Be careful DD, your communication gets too poignant and hits right to the heart of it all. It is strange, but posts like this disappear into the ether. Get buried under the weight of all that mularky upon mularky or fly away home.
For me, there are just a few words on which to meditate…
Liau…Askan…life
Brain tumor…DCVax(R)…personalized…immune therapy
Dendritic cell…memory…killer T cells… long tail survival
FDA - efficacy - MHRA - Large scale manufacturing - EMEA - safety
Just repeat
Thank you for elaborating Biosect. When people ask why is this taking so long, you have to think theough the complexities here and how different they are from a standard FDA process. I really don’t see any reason to complain about the regulator status, as we don’t know and can’t assume trouble. What I see is regulators collaborating with the company on elements of trial design, trial conduct, data analysis, manufacturing review, and distribution system management.
FUDsters will FUD anywhere there is doubt or lack of clarity. They cannot speak publicly for the US regulator. This is well known. So they haven’t and that includes clinicaltrials.gov
Which is it LC, DCVax is effective and saves lives or it doesn’t?
This position of yours is news to everyone here.
You can get DCvax in the UK if you have lots of cash, but otherwise, the case needs to be clear or the evil empire will deny the claims in the US
How true, Fireman?
Why would anyone look at the developments of the past year as positive progress and align their ideas to the likes of posters like me or Flipper, Lykiri, keEsq, Iwasadiver or Doc, etc, etc, etc. Why should anyone look to people with expertise in areas relevant to this discussion when our motivations are so impure?
We should all stop and listen to those who claim no stake here and are all spending so much time doing a public debate a service by exposing LL as the sham that she is, shouldn’t we?
Thank you for your wise and learned opinions. You are doing a great job dispelling those who are working against the forces that attempt to derail mankind advancements in healthcare by spewing nonsense about living longer and such.
I can’t even imagine how difficult the manufacturing process with its QC, QA, and validation requirements will be. This alone probably tale a lot if regulatory back and forth…but forthcoming it is.
I mispoke and misread Bob. I did assume you are long and support Survival as a primary outcome for GBM.
An ode to that smell
ChiU guy, again thank you for the complement and I want to add a piece.
I know that I can look over the moon about Dr. Linda Liau…How could you not be?
When the other side bashes the trial design, they bash Linda Liau.
When the other side bashes the SAP, they bash Linda Liau
When the other side bashes the pending publication, they bash Linda Liau.
When the other side bashes the Regulatory process of EUR, they bash Linda Liau and Keymours Ashkan as well as two very fine regulators.
When the other side bashes the a drug as failed while UCLA runs a combo trial, they bash Linda Liau.
When the other side bashes the idea that FDA is on board they forget that there is an open EAP if they wanted it and there is an ongoing US trial approved in the midst of this who hah, they bash Linda Liau.
When the other side bashes they say the company is hiding bad data, they bash Linda Liau.
When the other side bashes the company has not moved the regulatory ball forward in the US, they bash Linda Liau and Mt. Sinai,
When the other side bashes the posters on this board who defend the actions related to the conduct of this trial from beginning to end, they bash Linda Liau…the Alpha and the Omega for this trial.
I think Linda Liau deserves a little MI Dendream lavashing of praise and defender of her good name against hoodbums. I believe in Fairness as well as Balance.
I know you are being sarcastic Bob, but I do want to add here just for the record and those listening from home.
Progression is a surrogate endpoint meaning it can stand in for the true endpoint because it represents it very well. You see if you progressed with GBM before DCVax, one could be reasonably certain death would be knocking soon.
You can no longer assume this because the new STANDARD OF CARE can cause pseudoprogression. Anything tested on top of that SOC will have to be suspect of a progression. Now, the FDA has very standard ways to deal withthis type of confounding of variables. The first step is to look again at a later date like 3 or 6 months depending on the condition. The next is to have blinded reviewers adjudicate cases so that borderline calls can be made. That is usually a committee of 3 experts not otherwise involved in the trial.
Sound familiar….
Thank you, sukus. Keep doing what you do to lift others up! They are messing with us so we need each other’s strength from time to time.
What are the shorts gonna do if we are seeing project Orbis and Cert approvals don’t get posted immediately and this is a ‘coming soon’ campaign, and CRL is ready to manufacture in North America and they are under a new contract now and the endpoints are globally accepted and the NEJM is ready to publish soon, and the original randomized cohorts are statistically different on Overall Survival, and rGBM is positive, and the pseudoprogression substudy is is also positive, and they will be signing a comarketing agreement?
What will they do then and how will they cover?
Certainly not with any of my or my minions shares. Will they cover with yours? Will you wait and see or has fear gotten the best of you?
Iron Mike, you must have stopped reading after the set up. The hook followed…
will be analyzed using three different statistical approaches and that any one ‘Yes’ leads to proof that the primary was successful…see also Linda Liau presentation to Mt Sinai on May 19, 2021
Iron Mike, we learned That the primary endpoint which Lykiri definitively proved to us today has been absolutely accepted by EMEA, will be analyzed using three different statistical approaches and that any one ‘Yes’ leads to proof that the primary was successful…see also Linda Liau presentation to Mt Sinai on May 19, 2021.
War in the East…War in the West…War up North…War down South…this a War…A War….A WAR
E ……. …. b … ….. X ….. … n
… W … BOOOM! … … E
… … N … ……. N
…..A … …… .. A …… E
In American football, they refer to this period as running out the clock.
You already have victory locked up. You can’t stop playing until the final whistle blows. You have to execute the Xs and Os still or really anything can happen, I saw that U Texas runback where they shuffled and spun and tossed backwards dozens of times to do what could not be done. So you have to run out the clock. Then you can claim your victory.
And then all your fans can storm the field, claim the upset victory of a lifetime. Tear down the goal posts and help make national news in doing so. Get drunk, s€rew, party, pop champaign and do everything you do when you are so joyfully Ecstatic that yoi go nuts.
LCpastdateman,I have already answered this question this morning.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=
I think most people recognize this but just to put it out there for y’all, I will take a few moments.
Physicians care about patients. Sometimes people think statements like that are opinion, they are not. They are fact. Great physicians are collegial and friendly, build relationships with their peers. Relationships of trust. Outstanding physicians lead the field and help their colleagues continue to adapt and do what is best for all patients, everywhere Western medicine finds a rock on which to stand.
Those physicians know what they are doing and with very few exceptions understand their influence and use it with great intentions. Their credibility and reputation requires this actually. They are real people with whom you can speak as guide, advisor, friend, acquaintance, giver of hope, provider of dreams, healing hands that give life, purveyor of horrible, terrible, no good news in the best, easiest and most empathetic way possible but truth must be delivered so that all can prepare.
I believe in Linda Liau and Keymours Ashkan. Deep down past my bone and through my marrow and into my light which I shine for you so that you too can receive the power that The Great and Wonderful, Healer to Mankind Linda Liau will share with you too if you need it. She just has to help push this ball past the golalkeeper and into the goal for the victory.
I believe in Linda Liau.