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I haven’t read the board since this posting really, so I can only gauge response based on a naysayers reply to me. What she is doing in my mind is beginning to demonstrate that DCVax is so much part of every solution that it need not even be mentioned sometimes. Oh, of course they got DCVax (it is my standard of care).
I don’t see her fumbling to find words on the topic of FDA as a negative indicator, but understand why some could She knows she must be super careful. Let’s face it, the demeanor of the other expert speaks volumes. Welcome to our home, can I throw the first punch from your left flank?
She let out some sensitive info immediately. She confirmed what I consider SAP discussion where FDA did not reply by 30 days… consider they had presubmission meetings with Q&A and feedback and that should make everyone rest a little bit easier.
After that, I doubt she has any information other than submission status which she basically also confirmed embedded within the disappointment of not knowing an answer. I am reasonably confident that she would not be kept inside the loop on other actions beyond that, as they are super confidential and she is not an officer of the company. Physicians make clear to us their independence of mind and body. There are many reasons not to share information.
Yes, she is disappointed. Yes, he too seemed frustrated, but was he frustrated that he couldn’t pry information from a hmmmmm friendly rival? I think as a lead question it says a lot. The reply must be put into context.
FDAs different in the sense that…
We submitted things and we didn’t hear anything back.
I think that confirms what I have been saying and how that relates to things like clinical trials.gov and PRs about endpoints. She seemed almost to plead like decision time is soon. She would not be looped in to any of the negotiations should they be taking place. At most she would kniw a PDUFA or maybe a target date.
I smell a storm brewing
OMG Lykiri - I bow to your amazing sleuth activity. Crazy good lecture that picks up pace as it raises expectations. It is just missing a mano a mano scene.
GBM is an orphan disease with the highest of unmet medical needs
The situation with regards to everything NWBO has never been seen by the likes of me before.
Have you every seen the unblind KM OS curves with hashmarks for lives still marching or lost to follow up if they are less than 3 years status published ahead of datalock of a p3 trial before? Unheard of.
Have you every seen a company survive a short attack that starved necessary funding to the tune hundreds of millions of dollars over several years, but none the less stand tall as they cross the finish line with more IP than is needed to build a bridge to Hawaii? Remarkable
Have you ever seen the lead investigator/creator accept so many awards for that invention and advance ahead of its official validation including the rarely achieved and prestigious American Academy of Medicine? Please have an open mind to the possibilities these rare feats display.
Read closely the words in this Motley Fool articles where disclosure is discussed. I don’t feel like doing any more work than this.
Regardless your research, companies do not have to disclose filing a BLA, acceptance of a BLA, communication with FDA about the BLA, status of the draft label, preprint orders with special service operators, any of the steps along the way really. Approval, or an Approvable letter though…those get disclosed by FDA.
https://www.fool.com/investing/stock-market/market-sectors/healthcare/pharmaceutical-stocks/pdufa-date/
Often companies have the final draft label minus minor grammatical tweaks well ahead of receiving the approval letter. They already know the answer but it isn’t official and they can’t and don’t leak this information. They can line up contracts and all thing necessary to launch. They can even print material “at risk.” How else do you think product can be available on Monday after receiving the letter on Friday?
An absolutely reasonable belief system based on logical deduction.
When one asks oneself open ended questions like how and why, one is able to open their minds to a fuller view of logical options until eliminating possibilities one by one.
There is an absolutely logical option where NWBO and the journal are coordinating release together. Since we know so few data points, many options are available. The only data point I can possibly add is that if they needed to move on to a second journal, they would have done so a few moons ago. At the very least, they are deep into editing.
In my mind, and so far as I have seen on this board, only one possible explanation remains for the reason for the halt. Every option discussed other than a regulator calling for a halt in new screening and removal of placebo as an option after DSM evaluation of deaths in unblind fashion, has been thoroughly beaten back. I only reiterate that because when one considers that, it adds credence to your theory.
You know, after they officially locked the database, they found out the true reason for the halt themselves… add this to Linda Liau and her study as well as Askan’s not so little open label trial called Specials. How long do you think they could withhold negative information from them and their prospective patients?
A journal was ready to be published shortly after May, 19th. Anyone viewing the Mt. Sinai Memorial Lecture saw that she had the full story right up to the Statistical Analysis Plan to demonstrate success already laid out clearly. The rest writes itself. She has already written a future of GBM review article and is awaiting the first by all signs. She was ready shortly after that talk, so count forward from June and you are reasonably close one way or the other. Using these deductions, before asking why and…
You are in the ballpark.
Trying to dig a deep den, the fox hits rock just beneath the surface. Be gone with you animals of the hunt, and make way for the Mardi Gras parade rolling on in. Everybody’s dancing and there are fireworks, calliopes and even some clowns.
You do not have to make a filing public and FDA leaves that to a company to decide. You do have to make a rejection public and quite often it is due to not adequately preparing commercial manufacturing or its quality assurance. That is where a lot of companies get tripped up.
The results will be GROUND SHAKING.
If you are a neurooncologist right now you are thinking, even that 10% I gave 3 extra years where never really GBM. I can’t do anything but a small boost at a heavy cost.
Then , the will see about 35% of those originally treated make 3 years and like 25-30% see 5 years where it levels off.
Thank you Senti! Looking forward to the refresher
I am looking forward to taking an extended vacation soon…one that may never end.
Here is to the coming weeks!
Beware the Ides of March
Can someone reply to me with the post citing that hour long Youtube interview with the Texas lawyer who has taken on illegal shorting successfully?
I want to watch it again. This time I might pop some popcorn with extra salt and real butter and put it on the big screen.
Major Tom
ATL et al, Thank you for putting these pieces together so clearly and concisely.
From what you day this also puts to rest the update the clincialtrials.gov or else crowd too. They are acknowledging the need for secrecy at times during the regulatory process and leave that to the discretion of the company through a quiet period.
It is amazing how every damn thing just keeps coming our way.
Sukus when you say “moat” do you mean in the sense of a water barrier?
Like say a moat around the castle that you overtake by defeating the knights who are heavily armed and well staffed. Their might amplified in the stronghold of the citadel.
It is like that except that LP and her crew have that new polymer from MIT sprayed on lightweight steel armor. And, after taking the castle she then sprays that too with the MIT polymer making it a hell of a lot stronger than when it was the dominion of knights. With the knights now in the Gevangepoort in chains under the watchful eyes of domestic friends of Cofer’s.
That kind of moat?
What is this DCVax-Lung that bears tried to create panty ruffling about?
Is there any relation?
In academia there are predominantly clinicians, educators, clinical trialists, and researchers. It is the role of the researcher to continue to forge new paths and attempt escape velocity towards a new world free of whatever disease they investigate.
Industry also does discovery and development, actually on a much larger scale. In the end the two collaborate and the question is at what stage, what price, and how much does the University retain. UPenn is not the only game in town by far.
Generally speaking, I find these collaborations stick for many, many years officially and informally. Synergies get built.
No offense Poorman or Red, but I can’t get behind the idea of calling ingestion of Old Crow a party for anyone.
She provided me an opportunity to consolidate holdings in the next humongous Biotech advancement while securing the place for that product as SOC in a lucrative indication. Simultaneously she built out manufacturing capacity on a razor thin budget to support launch capability in all major markets.
But I am an investor, not a trader of this company’s stock
Thanks for this
I read a Twitter posting on the #NWBO thread that drew the line from the short attacks which starved DNDN and eventually prevented them from advancing their technology towards possible profitability to an eventual China take over of the Dendritic cell manufacturing technology.
I don’t know if that theory is true or not, but it makes you see just how vulnerable or finacial systems are due to illegal naked and synthetic share shorting. While Washington and NYC fat cats fleece America, our enemies are given a back door to our technology advances.
This has to end.
So you are saying one by one a company can not only win new DCVax indications but also simultaneously corner the checkpoint market in that indication and essentially extending patent life for that CI too? Does this suggest to you a plan to stay independent?
Seems like the proverbial Catbird Seat.
I honestly cannot believe any short/bears even exist anymore. Do they think they can starve her of financings? Do they honestly believe that NWBO has not submitted BLAs already? Does anyone truly believe that BLAs would be held for a journal publication?
What frame of reality do people live in? I am dumbfounded at this point to think anyone with any degree of factual DD could put money on any size bet against LP at this point. If you were not amazed by her brilliance and maneuvering before 2021, how can you see these patents pull through and have any doubts remaining?
I am not sure which you are referring to. Is it Sanofi or the other two? Which has more cash on hand?
They also already manufacture cell therapies
He s agreeing with and adding to LC2020…enough said
I agree that the two are unrelated other than it is Bosch and Liau involved in both. The timing aspect has nothing to do with them being related. All I am saying is that a journal will work with a company and align release of a publication to the company’s wishes if it is feasible. This happens.
I think the company is asking to hold the publication so that they can control the sequence and timing.
Regulators don’t look to journals and journals don’t look to regulators, but companies look at both.
What is your background Reefrad? I am curious if you have any basis of experience on which to base your judgement of whether or not a full page advertisement qualifies as premarket promotion, oh yea, or as those that like to belittle the situation like to refer to the tote bag.
Juno and Kite - the autologous CAR-T?
Those products cost a fortune to make and the net is low.
IMO - the focus of importance on Gross or Net differs between small & large biopharma.
You choose your view, I’ll choose mine.
To me the money needed to be spent one way or another, but additional resources, know-how, and hiring was required in addition to that funding. She could have worked with an outsider, but chose to work with insiders.
The time complaint is so penny wise pound foolish, I can’t take it anymore. To move forward with the regulatory path any sooner would have led to a much smaller market for DCVax long term. They served shareholders best by waiting and many retailers just can’t see that.
I see my self as more of a Willie, but thanks!
It can be mutually beneficial. It was certainly fodder for the attack, but the backstop was more useful than most anyone gives credit. The advances were shared and the production sits firmly in our hands after Flashworks, We hold the patents, we own the process, we have everything of substantial value. They are a service provider. This industry runs on service providers.
FLASHWORKS, I know what it is called, I choose my own spelling…it has more pizzazz.
Those closed down stand alone Kroegers and Walgreens near you. They are the perfect size for two clean rooms and a front office… if only cold storage were more simple…IT IS.
The journal is on hold for the regulator, not the reverse.
Journals will work with companies on timing.
Show me who else they possibly could be associated with right now. Do you have any background in pharmaceutical production?
I worked my way through graduate school doing much of just what is listed there, smaller scale and simpler times for sure. Perhaps you were a neysayer when the same was said about Advent expansion. The old Cognate stories are just that OLD. If you can’t see the brilliance behind both the Cognate and Advent maneuvers then you, my friend play a different level of chess than some other posters here and can’t even sit in the stands to watch the level that LP plays at. Those moves were downright brilliant, and good for shareholders. Delaying study closure and potential approval for the SOC stamp of approval, down right amazing for shareholders.
If you cannot put yourself in the context of the moment you cannot play the Monday morning quarterback on talk radio.
I beg to differ. I know that you understand how much is available in reserves amongst the biggest companies with the sharpest patent cliffs.
GBM will be a very big market. Label expansion in rescectable tumors is obvious.
$20 B neglects to fully value the pipeline potential as well as the bidding war that then brews. Any company that has dipped their toe into cell therapy is holding a placard.
A whap bop a lubop a whap bam BOOM!
Honestly, any Biotech with sufficient clean room capacity and an ability to quickly build storage is in the game if they choose.
There is a whole lot of guacamole on the table right now. A whole lot of guacamole.
GBM is currently about a $3B market. Nearly every patient in that figure will have DCVax added to their regimen. That leads to a substantial growth in the MARKET for GBM.
Do your own math, but I estimate DCVax-L for GBM quickly plateaus at a run rate of about $4-5B. After that price increases will account for its growth in that indication. DCVax is already being used in other indications within the United Kingdom.
Maybe he is talking about breast cancer in men. Those numbers are similar to GBM.
Rare disease…different views about a drug candidate (and premarket promotion) from within and without.
Those jobs posted at Cognate are commercial production jobs, not research btach manufacturing You don’t hire all thise positions unless you will soon have something to produce, assure quality of the produced product, and validate the process.
Totegate….those people are Frazy.
DCVax is without doubt in my my mind, coming soon to a neurosurgeon near you. COVID may have extended the ticking of the clock, but I know premarket promotion when I see it. It isn’t even a stretch, read between the patent and production lines. How many signs does one need?
Coming Soon
To all the patent experts I’ve loved before,
I followed them all and learned so much more,
They took me by surprise,
I looked them in their eyes,
To all the patent experts on this board!
Thanks again and again, Lykiri
Shashi Murthy…dun dun…dun dun dun…Shashi Murthy…dun dun…dun dun dun…Shashi Murthy..dun dun..dun dun dun
Kwok Pang boomba yea…Kwok Pang Boomba yea…
Shashi murthy. YEA!
I just had to kick up a cheer. As I have been called a cheer leader and wear the hat proudly.
This is a pointless and silly argument. Once it gets tested in any culture, animal or human it is part of the platform.
If they listed the pipeline by indications and included all preclinical and current clinical status, the graphic would be huge. Just because they haven’t taken the next step doesn’t kill the program.
https://nwbio.com/nw-bio-presents-updated-data-from-dcvax-direct-phase-i-trial-at-5th-annual-smi-cancer-vaccines-conference-in-london/
https://www.biospace.com/article/releases/nw-biotechnology-industry-organization-bio-making-a-joint-poster-presentation-on-its-dcvax-direct-trial-at-the-b-29th-annual-sitc-meeting-b-/