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Apart from the date of the lawsuit filing being off this a pretty interesting piece:
https://substack.com/inbox/post/140934377
FWIW - My thoughts on MHRA MAA timeline:
Against fast approval:
It's a 1.7 mn page document so a lot to go through.
It's a biologic.
It's personalized.
Involves handling of tissue and blood.
The manufacturing is much more important than for a normal drug and they have to be happy with that (which I think they are).
For Fast Approval:
They have been treating patients for several years and if you include those from the trial and the specials program it is in the 100's.
There is an unmet need for a deadly disease.
The safety profile is excellent.
GBM has a much higher profile in the UK than in the U.S. both amongst the public and politicians (Parliamentary committee on brain cancer).
The UK wants to set itself up as a major player in the global pharmaceuticals with streamline approval process.
Medical community backing.
My guess is that the MHRA uses full 80 days to review but unless they find some real glaring errors that it gets approved then. That puts it about March 11th.
Given how wrong I've been about everything and it's NWBO I'm probably too optimistic. But I like my glasses ½ full.
Reardon has ties to Nevercure.
Wow! It would be very interesting to see how that has evolved over the past few years. My bet is that none of these brokers want to have Cohen Millstein see this during discovery and will look to settle with NWBO very quickly if the MTD is dismissed.
It might be but the problem is that Citadel is not a public company so the records aren't available.
It's reading garbage like this that I very rarely visit the boards or write anything.
Many people wonder how big the naked short position in NWBO is, if there is one at all. Given the 24/7/365 attacks on the company and alleged price manipulation, it appears that the naked short position may be massive. But how big? As naked shorting is illegal there is no easy way of finding out. If it exists, it may possibly be hidden by the ability of the market makers to sell stock they don’t own as part of their duty to keep an orderly market. Finding the data on this is difficult as many of the most active market makers in NWBO are not public and there is no available information. However, Virtu Financial is listed and its annual reports have some interesting information as follows:
2020
Revenue: $2.6bn
Contribution from Market Making: $2.45bn
Financial Instruments Sold Not Yet Purchased: $2.9bn
2022
Revenue: $2.4bn
Contribution from Market Making: $1.8bn
Financial Instruments Sold Not Yet Purchased: $4.2bn
Over the period Virtu had a -26.5% fall in revenue from market making yet increased securities sold but not yet purchased by 44.8%!
To be clear here I am not alleging that Virtu has engaged in naked shorting or has done anything illegal. What I am saying though is that the ability of market makers to sell things they don’t own may hold the key to how a very large naked short position in NWBO may be hidden. If the motion to dismiss the lawsuit against Citadel, Virtu, etc. is denied I reckon that details of NWBO stock these brokers may have sold but not yet delivered will be one of the first items that Cohen Millstein demands during the discovery process.
What I don't understand is if there a a number of counterfeit shares outstanding why this isn't reflected at the ASM voting. If, as some people say, there are a billion or more naked short shares why wasn't this total votes well over the billion share in issued float?
NICE is NOT in charge on this trial or any other. The purpose of NICE is to do a cost benefit analysis on approved new treatments to see if the NHS should pay for it. As DCVax is not yet approved this analysis has not been undertaken.
NWBO Longs vs. Shorts
We know they are lying
They know they are lying
They know we know they are lying
We know that they know that we know they are lying
And still they continue to lie.
A. Solzhenitsyn.
Not yet. They won't sell until they have approval for at least one indication (GBM) and probably not until they have it for other cancers.
There are several types of arrangements with different sorts of partners that would be very bullish for the company and shareholders. Publication of the JAMA article opens the way for these.
Here are the choices for NWBO to get rid of the shorts:
1. Pay protection money
2. Litigate
3. Start disappearing people - Cofer is experienced at this
While 3 is appealing 2 is probably the best.
Oh, the weather outside is frightful
But the fire is so delightful
And since we've no place to go
Let it SNO, let it SNO, let it SNO
47 days to LL speech
45 days to late breaking abstracts are published
PGSD - thanks for posting. This piqued my interest so I've dug a little deeper. A friend has sent me the four page referenced article from a journal called Clinical Neuropharmacology (strikes me as an odd place for a piece about GBM). After reading it I would like to make several points:
1. The four authors of the paper, Drs. Long Tan, Jie Peng, Ping Liu and Qi Wu work at the The First Hospital of Changsha, Hunan Province China. None of them identify as neuro-oncologists (two identify as neurosurgeons, one as a respiratory doctor and one as an ER doctor).
2. The basis of the article is, and I quote, "We search PubMed, EMBASE, Web of science, EBSCO, and Cochrane library databases through December 2019 for randomized controlled trials assessing the efficacy and safety of dendritic cell vaccine for newly diagnosed glioblastoma."
3. Using this methodology they found three studies which matched this criteria - Buchroithner 2018, Cho 2012 and Wen 2019.
4. Two of the studies Cho and Buchroithner had very small enrollments (18 and 34 respectively) so the validity of these study results could be called into question.
5. However, and most importantly, NONE of these studies were conducted using DCVax.
6. Lastly, DCVax isn't even mentioned in the article.
In sum this journal article was done by doctors who are not neuro-oncolgists, conducted via web search, using studies with small sample sizes and most importantly NOT EVEN ABOUT DCVax. Furthermore neither DCVax nor NWBO are even mentioned in the journal article. Why on earth was this study was even referenced in the Cloughesy presentation is a mystery to me.
If DCVax, like many of us suspect, proves to be the way forward for GBM then one wonders what happens to Novacure. At best it delays progression of GBM but does not halt it. The stock price is down from almost $225 to $77 but this still equates to a $8.6bn market cap. Given the choice of DCVax or a helmet I wonder how many doctors will recommend the latter. Insiders have been selling which is never a good indication. I wonder if their own view of the company is a dim as mine. I suspect soon that the market caps of NWBO and NVCR will be reversed.
If I'm not mistaken Dr. Ashkan did this several years ago and said that DCVax should be approved. His plea fell on deaf ears.
The latest kerfuffle AF has created is actually good news for us longs. Trotting out a line of attack that has been disproven numerous times is a sign of pure desperation by the shorts. The size of their collective short position must be massive and when the squeeze happens it will be enormous. Watching them scramble to buy stock will be fun to watch.
I'm not sure if someone has posted this or not but if they have excuse the repetition. This study was done at Houston Methodist with collaboration from M.D.Anderson. While DCVax was not part of the study I guess the findings are applicable.
https://read.houstonmethodist.org/mathematical-models
Hmmm... If Alex Tabbarrok of George Mason Univ. is right in his calculation then how much is NWBO really worth if it could reduce cancer mortality by say only 2%?:
"Looking at the future, if medical research could reduce cancer mortality by just 10 percent, it would be worth $5 trillion to U.S. citizens (and even more taking into account the rest of the world)."
It's on P. 52 of this:
https://mason.gmu.edu/~atabarro//Launching%20The%20Innovation%20Renaissance.pdf
Exactly.
Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.
Winston Churchill
99.99999% It's the way forward and the Phase 1 trial for Direct paves the way. The new trials will likely be single armed and measured against existing standard of care. This will shorten length of trial to probably only 1 year before read-out.
Sometime in the coming weeks/months NWBO will launch several trials on other solid tumor cancers using DCVax-Direct
Sometime in the coming weeks/months NWBO stock will be uplisted
Sometime in the coming weeks/months NWBO will do a reverse split
Sometime in the coming weeks/months NWBO will raise capital to fund the above mentioned trials
I don't know. But if he wrote the last one he probably had at least some input into the current one.
I believe Paul Mulholland wrote the article that appeared in the Journal of Translational Medicine
The other thing to note about the UK is the government wants to make the UK a global leader in medical innovation and this is especially true since Brexit. They were one of the first to approve a Covid vaccine and I strongly believe they will be the first to approve DCVax.
I'm not anti-chart but if the stock is as manipulated as myself and many others believe what use are they?
Thank you
Fair value will be achieved when the company is bought by a big pharma. Everyday that goes by the value of the company goes up as they work towards releasing TLD, getting approval and setting up new trials for other sold tumor cancers. This may not be reflected in the share price but as long as you can hold this does not matter.
At the time of the latest loan of $11mn, the data had already been locked for about four months. If I was making that loan I'd either want to see TLD (in turn I'd sign an NDA) or I would want assurances that the company had seen TLD. If management had seen TLD and it was bad they are, from what I understand, under obligation by the SEC to report that.
He helped produced the SAP's. Was it his idea to change primary endpoint to mOS?
Exactly
If I were BMY, Pfizer, Amgen, Gilead or any other company wanting to be relevant in immunotherapy I'd be on the phone with LP.
Long time shareholder who rarely posts. What spurs me to write this morning is that I think many of you are overlooking a significant change in the nature of our investment. At market close on Friday I owned shares in a company that has what looks like a breakthrough in the treatment of glioblastoma which according to the interim data from 2018 extended the mOS for several months and is an effective cure for a certain segment of the treatment group.
I own a different company now. Going from the slide presented by Linda Liau in her talk on Friday (p.29) DCVAX in combination with Keytruda ELIMINATES TUMORS. Granted that this study is not large and has not been going on for a long time. However, that is a bold statement to be made by one of the world's leading oncologists and one that is probably not made lightly. In addition, as we know GBM is amongst the most difficult cancers to treat. If this combination eliminates GBM then it probably has the same effect on all other solid tumors.
The rest of you can interpret or ignore the slide as you like and time may prove me wrong. But I think I now own shares in a company that literally has the cure for cancer.
You didn't answer my question. How do you know they haven't seen TLD? It is merely a conjecture on your part as is it a conjecture on the part of anyone who says they have seen TLD.
How do you know TLD is not known to the company?
Thanks. I've been in this stock for years and to quote Churchill I think we are at this phase:
“This is not the end, this is not even the beginning of the end, this is just perhaps the end of the beginning.”
NYU Professor of Marketing Scott Galloway has an interesting thesis about successful companies. He says that any company that creates more than $10 billion in shareholder value does so by either extending time or enhancing time. From the piece I’ve linked to below he uses Microsoft and LVMH as examples:
“Microsoft saves you years in efficiency (extend). LVMH allows you to enjoy the finest in life and increases your selection set of mates (enhance).”
He highlights other companies that do this and calls them “Time Machines”.
Using this approach to analyze Northwest Bio one can’t but help think that the DCVax platform is potentially one of the greatest time machines ever discovered. The ability to harness ones own immune system in a safe and effective way to battle cancer is truly revolutionary. How much shareholder value can be created by such a time machine?
https://www.profgalloway.com/time-machines-species-failure