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Do you think it would be treated similar to this?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6445645/
It is also a nuclear medicine, so it would also be regulated by a completely different agency.
Since I am a firm believer that approvals will be coming through soon, I tend to agree with you. They aren’t prepared to commercialize themselves. Not even close.
I personally believe that the Journal article is being held for approval. This is just gut, I don’t really have anything solid to base it on. I just don’t see any advantage to releasing TLD before approval is imminent. The journal would be like all other positive news. It would give manipulators another reason to manipulate.
With approval you have something of a rock-solid tangible asset. The mystery is removed.
Muee88, my question is why bother with patents?
According to Scotty, they are sitting back collecting warrant fees while they let a failed trial slip away into oblivion.
Would you go after the full market potential of the GBM SOC which probably runs at 80-85% of all diagnosed, OR, would you want at best half of the patients that progress on the SOC, maybe 20-25% of the full market?
Seems like a lot of guacamole to me. Mucho bueno, guacamole con limon y tequila privada.
The current market estimate will grow substantially when a significant advance is offered. That is a lot of fresh guacamole we bought with those extra years. A whole lot of guacamole.
For simplification…
$5-6B x 0.75 = X 5 yrs =
$3.5B x 0.2 = X 9 years =
A whole lot of guacamole
Currently, about 35-40% of those that receive DCVax upfront will reach 3 year survival. There will still be space for later line therapy when the SOC fails.
The thing you have to ask yourself about the wait and alternatives, what would have happened if?
To be the standard of care means that you will receive a super majority share of the advanced markets. As a later line, you get a smaller share of what remains as rGBM.
Hmmm… I wonder why those other companies, you know, the ones with the approved trial designs with Hybrid ECAs as comparators, I wonder why they started with the much smaller market potential.
Ralph, Thank you for sharing your story. I am always strengthened to know that so many longs have found their way to this company because of a sincere desire to be part of something bigger than anything Wallstreet has to offer. Of course, it doesn’t hurt to hit the jackpot along the way.
I have been fortunate in my career to have made a positive impact on several very bad diseases. It feels very good to play even a small part in bringing a life-saving therapy to suffering patients. For those here who have invested rather than traded this stock, the reward will be a very sweet satisfaction.
Bitter sweet, but much more sweet than bitter.
Did I say typo or did I say spelling error?
Seems to me it wasn’t spelled correctly, but thank you for your critical eye. Obviously, no one knew what I was typing about due to the error that was so critical that it required two posts of correction from you.
I am sorry for your loss, Gary
Just to try to lighten the board up again, I am posting the hands down winner of the Bar Joke Challenge.
I am calling it the Big Les Award. Ralphazard is a guy who knows his way around science and manufacturing while also being a clever word smyth.
These are commercial production jobs folks with Cognate US-Canada. People criticized the speculators of the Advent expansion…yea, well who is laughing now?
The variance among hospitals between normal ranges of pretty standard labs can be quite large, some labs can be downright questionable. I Am not sure how you would accomplish QC, QA and Validation of your product with so may different locations and practices. Hospitals aren’t equipped to store and monitor temperates to guarantee stability over time for manufactured doses. Patients would have no way to be certain the product they receive is even still fully active…that seems like a recipe for a marketing disaster. The manufacture is a big part of the cost/revenue justification. Why would you give those dollars away?
Espionage and reverse engineering are very real concerns. Losing control of your technology is asking someone to steal it from you..
I don’t doubt at all that they explored the concept. I don’t see it going any farther though. If cost savings is the goal, that would accomplish the opposite.
My old physician did a procedure that I have fairly regularly in his office and billed insurance $2400 plus anesthesiologist which was about $800. My new guy does it in the hospital outpatient procedure facility. This bill was $10,000 from the hospital, $1200 for the procedurist, $1400 for the out of network anesthesiologist, and $1100 for a required out of network radiologist read (the doc said ignore everything in that report, they don’t know how to properly read this disease, so we paid for quite literally no reason with no choice in the matter) $11k more because of the way hospitals bill.
And our industry is regularly demonized by not only the patients we cure, but also the physicians we turn into better healers…Americans can be clueless.
I am aligned to this viewpoint too, Biosect.
Not getting in between your current spat, just saying it is always the best idea not to do anything that may not be fully agreed to by the regulator. They may have even told NWBO not to update. We just don’t know.
Clin trials.gov are small potatoes and the AFs would have destroyed any bump anyway.
But hey, Adam has now left the building
Love it Cherrytree. Thank you for posting
Wonderful post Viking…that’s for the inside viewpoint. I agree that you usually see stage setting when results are mixed, and didn’t think about that angle before.
Viking, I appreciate the information that you shared. I am taking the replies not as doubt that they were evaluating and taking intitial steps on such a plan, but rather skepticism and criticism of the plan and whether it would be feasible from several angles.
I personally don’t think it a wise approach for many, many reasons, but it does show me they are not stuck with the type of thinking I always see in the industry which is ‘this how things have always been done.’
I posted my take on the IDH mutation work a long time ago which is this…
It is unlikely that in the window of time before database lock and SAP finalization that NWBO would have been able to obtain and test placebo patients from ECA trials to clean the ECA of IDH mutants. So why would NWBO undertake this?
My belief is that the data analysis will be post hoc and used a few ways. First, I believe it was essentially and FDA requirement so as to address concerns FDA has for future GBM trial once DCVax becomes SOC. They want to use treated DCVax arm in future comparisons and will likely require NWBO to run a 5 year open-label safety trial to beef this up. The other is that the post hoc analysis will be shared with both regulators and physicians as assurance that the efficacy seen was not limited to that patient type. Finally, since they are part of the trial but not part of current diagnostic criteria, I believe that the label will specifiy approval for both GBM and IDH mutant brain tumors. The collection of the data is a priori, but the analysis is post hoc or exploratory and part of what is considered sensitivity analysis.
Manufacturing capacity build out in US and UK to support what exactly?
Who has owned this stock only to sell now? What legitimate shares are changing hands? Any at all?
I personally have paid no attention to stock price ever since seeing the ABTA ads. Once things move from theoretical to reality we will all look back and regret not taking more of those synthetic shares off of their hands. Know what you hold!
Probably not, so may as well go somewhere else to complain
As I understand it, Flaskworks isn’t fully automated. I assumed there is still some work that needs to be performed under positive airflow, sterile conditions. Maybe I am wrong, or maybe all they need is a hood for each workstation.
I was under the impression that the devices would go into clean room where workstations would be set up. If they don’t need clean rooms at all, then that iis quite a barrier removed from the equation.
That is an awful lot of manufacturing related employees to be hired at Cognate to account for some small increase in production of some research product. It is obvious this is for commercialization of a product. Quality Assurance is a post production function, Validations are done on manufactured commercial product to validate that all the procedures were followed properly. Realistically, you are talking about $3M in salary and benefits minimum annually.
Denialism runs strong here.
DCvax for Brain Tumors, both GBM and IDH mutant is Coming Soon
Spelling isn’t my forte and I don’t have much time to edit. You will have to live with my common errors.
I think a wiser move would be to set up two dozen small manufacturing facilities throughout the US that also have the cold storage to store manufactured doses. That would have to reduce shipping time, costs and risks as well as provide enormous capacity. You wouldn’t need more than a few clean rooms at each location, bigger obviously in metro areas.
ChiU, The thing about Linda P is that she seems to “make no small plans “ like the Windy City’s fine urban planner, Daniel Burnham coined.
Once revenue starts flowing, there is no reason they can’t go after kill, clean and repair. Those fatty plaques in your arteries were caused by an immune cell and will need to be cleaned by an immune cell if it is to become permanent. Who knows where this company can grow when the cash to fuel research is available.
Some say editors at prestigious publications are arguing over details, others say it us all a scam, while still others suggest a plot to hand things over to vulture financiers.
My guess, they await the nod from a regulator to then give the nod to the publisher to then publish, announce approval and update Flashworks plans publicly. Sawston approval and coming on-line were just released a few weeks back. The dominos are falling.
We are in the calm before the Snow-pocalypse
Folks we have a hands down winner on the bar joke challenge.
You are all welcome to keep trying but Ralphazard has take us to school
Rabble rabble, grumble grumble, harrumph harrumph and a Bah Hum Bug to you!
Frizzle, frazzle, frickle, frack…Bah Humbug!
I prefer to look at all of the developments without dwelling on feelings of frustration and self-regret for not having seen what Flipper so plainly laid out regarding past timelines.
Those who work in or with Healthcare know that while much of the rest of the economy is still trying to pick itself up, Healthcare went back into lockdown 2 months ago. COVID is wreaking havoc on timelines. Even if we cross into March and possibly April, I have no doubt DCVax is coming soon to a center of excellence near you.
I can’t even maintain my concentration long enough to get through a third of that article before just skimming through. What I can digest is that the crew at Flashworks is pretty darn Bad-Ass.
Thanks for the post
Some day colleges of Biocellular engineering will call Sashi Murthy the Godfather of Personalized Immune cell manufacturing.
Realistically, play this mental game with me…assume approval is two months away and CRL can put 10 clean rooms on line. You will know the answer, but as I recall the build out was for like 20 rooms. Those 200 per month will carry you for a few months as sites ramp up. Then as the utilization spreads, CRL may be able to get up to maybe 500-600 per month. That buys you plenty of time to test and certify FLASHWORKS then rise up a full logarithmic step in capacity to meet full global demand for GBM plus spill over. After that, it is merely clean room and storage construction standing between them and a brave new world.
It has been in the background of my head all day now too
Hello friend, The timing of these openings is nearly impeccable. You can’t make this stuff up, really you can’t.
Flow cytometry specialist - are you kidding me, in Memphis, TN, can you not see the truth as it stares you in the phase? The Royal You, not you PQR.
Validations, Quality Assurance, Manufacturing, managers, engineers, doers, doers, doers. I am aggressive with recruitment. I expect to have a job filled within 30 days of posting it. Not sure how I calibrate.
How many clean rooms? How much staff is already in place? How many shifts, what is the ramp up time?
You don’t have to be anywhere near full capacity at launch. Complex institution-based treatments have a lot of official hoops to jump through before healers can heal. Plenty of time to service the speeeeedy while ramping up for early adopters, then release FLASHWORKS upon the world months down the line.
Charley says… I love my Good and Plenty
Charley says… It really rings a bell.
X rooms x 4-5 cases per room per shift x 2 shifts = plenty of capacity for launch so long as the ramp up plan is in place. Good and Plenty
Not to rehash, but the tot bag appeared after a full page advertisement.
I am not backing away from the idea that they were given the Green Light to premarket promote within the acceptable guidance, just that 6 months may be a bit of a moving target due to COVID. I am sticking with UK & US approval is coming soon. Just maybe a few more weeks than the three that remain on the clock.
Let me ask this, when you see structural or culture change there is a precipitating event. What was the precipiating event that finally pushed FDA to change their stance on external controls?
My answer is DCVax SAP submission followed by BLA completion. The rGBM Hybrid ECA designs were already approved despite the guidance be draft, and not the kind of draft that is immediately implemented as they are also known to do. Approving a drug based on this DRAFT is another story.
Parallel paths, both NWBO and FDA are able to focus on more than one thing at a time, and even coordinate those things.
Nice, That must be one big bar of gold. If they haven’t submitted a BLA, then why is Cognate hiring now?
I have to belive they need about 2-3 months to hire and onboard everyone. It appears my ‘coming soon’ end of February prediction may be off by a couple weeks. Darn COVID slows just about everything down.
A Flow Cytometry Analysis specialist, a Manufacturing Manager, and a Validation Engineer walk into a bar…
Finish the joke and tell me who it is on, please.
I am impervious to scare tactics with regards to this stock, because as you may have been paying attention, I understand KM, study conduct, and other critical trial information.
All is well and all is calm.
Meirluc, it just isn’t conceivable for the enrollment to have happened any other way.
The scary thing for bears is that the projection numbers…if you live to 36 months the median survival is xxx… these were based on the survival in the fisrt group (223 or less). When the final group marches through, all those numbers will go up which means the numbers for the treated cohort only may be even better still.
Imagine having a 4 in 10 chance of surviving 3 years and if so a median survival of like 10 years.
Why all the concern about the data? The original cohorts comparison of OS is positive anyway.
GGB, I am amaezed that they were able to keep me believing that Tomorrow was only a day away for so long, but at least I had accumulated while waiting.
I am not sure that I ever understand you, but I also believe you do not understand me, not really.
I believe in power battles everywhere for sure, and have no idea where you battle.
Not at all, creativity is in all of us but we channel it differently. Some people just can’t get along now can we, us humans on this board
Complexity of thought takes a lot of flexibility in a lot of different ways.
Once upon a time, someone told me that life is a game with winners and losers. They followed with most people are losers.
I chose to believe life has tens of thousands of games, some like playing cards have thousands of variations, one of them is like Dungeon & Dragons where Evil Knights and their Castles alongside wild hoardes of goblins and hobgoblins attack towns and small fiefdoms, while travel parties fight back. Some of those parties have charming theives, massive warriors, quick rangers and a wizard while others have clerics and assassins, witches and Valkyrie.
Others are like football, volleyball and boxing.
Yep, I remember this all now. Thanks, Senti.
I’ll say it now if I didn’t say it exactly this way then. Hogwash.
I indicated then I am nearly certain that I believe FDA would consider the imbalance still randomized since everyone else involved did not know it occurred, assumed randomization happened and all remained blinded. In 2019, Les still remained blinded. Technically, until sites were locked down and sometime thereafter, they could not really see where imbalance even sat and I am sure it is spread over many sites, where the last 32 enrolled.
I picture this, Les, Marnix LP and a few others siting around a table discussing the possibilities that explain a 32 imbalance of patients who substantially weakened my study by taking 2:1 randomization up to 2.34:1. A study that I am also led to believe has regulators somewhere halting me for some, the gods of trial design only know, reason…oops I mean halted new screening as otherwise everyone else just carried on forward as if nothing in the world just happened. And I am suppose to believe this at a time when everyone still says FDA is making them use the original endpoints…LOOK OUT FOR THE POTTED PLANT.
Yes, I am certain that something like this came out of somebody’s mouth in that meeting…“I don’t know maybe some flaw some where happened during randomization and somehow the system that corrects imbalances by every damn factor known to man even regionally went wrong this one time by such a huge number that no clinical scientist on earth out there is gonna believe us, but yea maybe that did happen…pause…if that’s the case then what the hell do we do?” That followed one of them saying…
“We can all see they stopped putting patients on placebo, so how do we answer them to get them to move past it?”
That same person afterwards said probably said something like, “Ok, but I can’t sell that so which of you is saying that, and it isn’t you Marnix? We need plausible deniability.”
“Ok, put on a nice Hawaiian shirt at least please, Les. We have a long time coming still and it would be nice to maintain some valuation in case we get desperate again.”
I picture this great big forrest with a party at a mansion by the big garden at dusk, then everyone is chased off by something and are scattered to wander this forrest seemingly alone.
At the center of the forrest has a wide circular meadow and a top the mound at the center is an 18 ft tall statue of the Sunsinger, victorious champion dressed in leather and metal with her arms spread wide as she looks up to embrace the sun.
That night the scattered party finds their way to a series of twisting and turning trails. On one trail moonlight shines upon the grotesque figure of a giant stone gargoyle guarding a desk full of officially stamped documents, aNother caused a screech heard far and wide as frightening monster steals away frozen coins of gold set in bronze. A ferocious Mintour destroying tools of some builders trade causes gasps amongst another party, while a Centauar sending flamming arrows at a tent housing physicians caring for wounded humans is carved bas relief into the sides of a granite cliff alonside one trail.
From above however, the viewer can see the beautiful interlacing network of paths all leading to the center, where the Sun Singer stands proudly waiting for each party to join her in worship of a glorious sun rise.