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Any idea why the delay for Ultomiris?
Critical read
I am seeing the same, but mine says it started at 11 am CST. Could we have missed it?
Do any of my finance regulation gurus here know? If a publicly traded partner were to want to take say a 10% stake in their partner company for say $15 and give that company say $10B cash for say all neurological oncology indications, would the shares need to actually be available in the approved shelf free of any potential lean a stock grant or warrant purchase would add?
I am basically postulating that a partnership announcement may require that we approve the shelf first. The fact that they may nit be able to ink the deal unless they have actual common shares available to them. The idea that the new shelf only accounts for current shares, outstanding warrants, employee options & grants plus the “C” share conversion to common signals they will not need to raise capital again before repurchasing large share amounts way down the road.
Thank you ChiU!
Hope all is well. We are getting so close to the prize now, my patience is turning to anxiety… the good kind of anxiety
So was the sale of class C shares necessary to show financial harm due to this primary claim?
And I have been ridiculed for suggest 5/10 was a sting operation…
He (or she) who laughs last, last laughs
Thank you, PQR my friend. Perhaps you saw that scumbag poking fun at management for filing this case calling them desperate.
I believe in psychology that is called displacement and maybe but I am not sure it is what kids these days call gas lighting.
That s the NYAS data presentation. I am looking for something entirely different
Can someone post the link to the youtube video of that Texas lawyer dude and his high tech buddy talking about how to electronically track share ownership over time to catch counterfeit shares?
Has anyone considered that the data published in JAMA was ready for prime time shortly after May 19, 2021 and talked about by LP n October 2021, was therefore ready for RA submission sometime about a year ago?
What makes people think the applications and/or approvals have been held up by the clinical data?
It wasn’t until June of this year that we learned he QC/QA testing protocols were ready and the FLASKWORKS apparatus testing was complete.
Manufacturing, it has always been about manufacturing for Linda and she has that solved now.
Hi Senti,
I hadn’t thought about the 10q angle although I would need to look closely at the verbiage used to see if they have wiggle room to operate freely with providing clarity.
Hope you are well and that your daughter can rest easy in her investment verysoon.
A SNO Plenary Session with CE credits says four things! Actually,…
1) Everyone who is someone, come one ,come all…Hear Ye, Hear Ye! We the experts of Western Neurosurgical Oncology, the Society of and for Neurooncology… We have ground breaking research to fill your mind with and results that will lift your SPIRITS! Come be ordained in the ministry of medicine once again and spread the WORD to all nations.
2) You, my loyal investors, and I, Linda Powers, CEO, CFO and Chairperson of the Board of Directors for Northwest Biotherapeutics declare VICTORY! Victory over the dark tides that pushed and pulled trying to sink us during the storm. Victory in our path to successful navigation of the oversight procedures and hurdles. And most importantly, victory over the Grim Reaper’s strangling hold on patients condemned to GBM. We did this together!
3) You have your peer-reviewed data already buster! Stop fretting about when New England Journal of Medicine or Lancet will publish the manuscript, a plenary presentation is referred to as presenting my paper to my colleagues for peer commentary.
4) PR release, Media event, Coverage and pressure on US Insurance Providers because if you think for one damn minute you will not cover this therapy once approved by FDA, be GD certain we will write the new Guidelines for the Treatment of Gliomas and other Brain Tumors and you do not hold the power of Life over Death. The Creator does and he/she has granted that power in the case of Neuro Oncology to us, not you!
Generic without doubt
Den = dendritic, cel = cellular product
As opposed to
SipuLeucel-T as in Provenge
Leu = mixed leukocyte product, cel = same
Senti, please explain why you believe this statement is proof that no application has been filed?
I personally have no idea what falls in and out of bounds under the “product matters” statement. Seems to me that responding to MHRA findings and preparing for commercial launch are “product matters.”
Hope you are well!
Dendream
CME are sponsored events and not ‘safe harbor’ scientific communication. They are subject to FDA and OIG oversight, aka, More serious consequences than peer review
That’s my chicken scratch on top from a few weeks back. MID
Ok, Gamestop,but ok
Have you paid any attention to what has happened with politics?
I think you underestimate the value this board played to the long side of the game and how when some leaders on the board got doomsday the corresponding drops that were seen. But again, I say played.
I don’t know who originally posted it here but thank you.. when I retweeted it I ran my scan over it and I hope you don’t mind. I never could figure out how to post pictures here.
— MI Dendream (@MDendream) July 12, 2022
Has anyone here been monitoring the ebb & flow of jobs coming on, going off and breadth of new jobs being posted at the old Cognate facility?
Some of the latest to come and go have been down right hilarious to read. What I haven’t fully kept count of was the numbers when more than one was listed under a designation, but the filled count by my tally is around 100+.
Every time I see the new Validations and Storage/shipping/testing jobs come and go, I get down right giggly.
Oh ha ha ha ha ha, Woooh ha ha ha ha ha. He he he he ha
Ha ha ha haaaaa!
Everyone just relax and treasure the moment. Chill. All is good.
BB, I think my problem with so much of the judgement cast on management is that people always seem to want to believe the negative possibilities or interpretation. When terms like “excuse” are used, you can usually replace it with the word “reason” and the connotation flips while the other flops.
I prefer to approach puzzles with logic and REASON.
And my questions should have used past tense…
How much DID this message board influence?
While I understand your position Flip, I have to say that I have read research that used multiple capture populations that basically summarizes like this. Hedge funds take a position long or short, then make a market around that base. Retail determines momentum. Institutions basically wait to see where momentum builds before jumping in and out.
So the question is twofold…
How much can message boards influence momentum? And relative to other stocks and MBs, how does this, frequently number 1 MB in volume with roughly 15K shareholders, message board index against those?
I give you gamestop, and I give you ASCO 2021.
Thanks, Hope. So easy for the scoundrels to cheat investors and starve companies of financing. They control all the information and can hide in plane sight.
That is awesome Chiu! It looks like the exclamation point was recently achieved.
You have a unique approach to chart analysis, but I believe it is a wicked accurate indicator that you chart.
As you pointed out Doc, the study end date is Nov 22 which happens to coincide with a 7 year data cut.
This tells me there is likely a pecking order to approvals. If this is true, I think it goes UK, US, Canada, EMA. I don’t think more than a few months would separate each of these. I was under the assumption that ORBIS made approvals simultaneous.
He is a regular on Twitter. Many have given up here which was the point
They couldn’t bankrupt LP as planned, so they resorted to trying to deflate the will power of longs and psychologically break them on May 10th to try shake lose enough shares to cover.
It didn’t happen. They are SK..rewed!
Agree, and most Medicare patients take a lot of generic products but when they need branded for bigger issues, the costs likely far exceed $1000 (even per month). If you have a good supplement cost to the consumer is quite low. Copay assistance programs are for people with commercial insurance. Payers sometimes use copays as penalties for taking the right treatment rather than the ‘preferred’ treatment. Preferred means they get the biggest rebate, not that it is more efficacious, better tolerated or safer…sometimes none of the three are true, usually at least two are not. A 20 or 30% copay can flat out deter patients from seeking appropriate care as it can be tens of thousands of dollars. Most companies will offer $0, $5, or $50 out-of-pocket copay programs. You will also want to have a bridge program which is free drug upfront until insurance battles can be won and kick-in on the micro and macro level. Minnesota, Michigan and Mass politicians have people fooled into thinking it is an ethical decision to ban these programs. Those three states have incredibly powerful payers who spend a ton on political support.
BTW I believe $300k is close to what is currently charged for the full course in the UK, maybe even less after converting pounds to dollars. They can probably aim higher for the US WAC price, keeping in mind that upfront will be higher but much of the cost is deferred over the next couple of years. It is the upfront dose or three that will likely be given out free through bridge for the first two years on market. If they can push this through medical benefit instead of pharmacy benefit this might be avoided, but I doubt they can get the whole loading dose billed that way. Even more doubtful subsequent doses can get billed that way.
Don’t get me wrong. The patient always comes first, second and third to me. That is precisely why you need to price this product properly. If you go slim, your penetration in the US and most secondary markets will be reduced. Americans don’t understand this side of the business and are quite frankly bipolar in their approach towards drug pricing. They all have a significant piece of there savings invested in drug stocks and healthcare industry assets and want big returns, but they want us to be charitable organizations at the same time.
You need to assume that in the US you will give 20% of your drug away free and another 20% significantly discounted for people with no and poor insurance coverage. Those are not make believe numbers, those are the base case estimates used. You will also be selling your government business away at a sizable discount, and giving disproportionate share hospitals an even bigger discount. Powerful PBMs/insurers will demand a rebate too. When you wrap it all together in the US your true net price is roughly 40% below WAC. Bare in mind as well, that your business in Slovakia, Greece, etc. operates at a loss when all is factored in because, those business units don’t have to factor in to the development and R&D expenses.
If you want to reach more patients, you need to price high for the well insured in the US. Places like Canada and Britain, well they get away just needing to cover their market costs and as single source payers, they don’t need to factor in free and subsidized drug. All the resources you need to create in the US to deliver your drug for those support programs as well as to navigate through the web of red tape the Evil Empire puts in place to deflate physicians and deny appropriate care cost massive dollars as well.
That price is in the name of maximal reach while still delivering the profit promise that US investors want when it is their 401k, but don’t want when they have to pay $500 per month premiums with an ever increasing deductibles with the possibility of a large copay. In most states that don’t have big powerful insurers like Minnesota and Massachusetts, the company will want to have a copay assistance program in place as well. Interestingly those states don’t allow it and have people fooled into questioning the ethics while they restrict their citizens access. Deduct that from the price you read about in the Boston Globe as well. But call my industry the enemy, meanwhile the hospital/institutions will likely bill $500-600k and actually recover about a 20% average margin as this will be a “buy and bill” product most likely. Of the 11%of healthcare costs associated with drugs, drug companies only take home about 6%. The rest goes to the providers, middlemen, and Evil Empire. Almost none of whom took any risk or any part in the development.
ME is more my wife’s genre than mine, but I appreciate the lyrics which are clearly about cancer survival but also a fitting storyline for our favorite investment.
You must not have much background in drug pricing then. It is a rare disease, manufacturing costs are high, free drug and patients support programs get baked into the US price as well as the US subsidizing smaller markets that can’t really afford Western medicine. You need to finance corporate infrastructure build both brick and mortar as well as human capital, and more importantly you need to finance R&D and product improvements. Oh yeah, we all invested so there is also a thing called profit.
CAR-Ts cost way more as do most all other orphan biotech disease drugs recently developed. If you buy the CAR-Ts are so expensive to manufacture there is barely any profit margin line, I have some beachfront property in The Florida Keys to sell you. Good luck reselling that in ten years. The tax burden from the conservative Cost estimates to raise the highways and bridges alone are going to sink that value to nothing.
Corporate hamster wheel…I love that imagery. I think of it more like a three rat cage with ten extra rats deliberately put in it so that all the rats are stressed out and start biting each other to see who has the sharpest teeth. I would just lie to run on that wheel at a steady pace and let the other rats bite it out, but they attack and one must engage.
This stuff is fairly cookbook, but the devil is in the details. The intro will cover GBM and the lack of advancements with hundreds of failure. The methods will discuss the original design, the changes made along the way, may discuss reason for halt in screening, and a brief review of the ECA construction and SAP. (I think you may get two papers in one journal discussing the build, the inclusion/exclusion analysis, and the external/internal validations performed OR perhaps it is this separate publication that has the big reveal on hold as the high impact journal may want that to come out first and LP/LL may not have anticipated that)
Then comes the analysis of endpoints. This will likely include way beyond what we have seen including possibly the now ad hoc endpoints 4 through 6 as well as some predictor data. It may also have the two top endpoints run without IDH confoundment.
The discussion will have some justification of the ECA design, likely some discussion of the conservative approach including IDH mutation being included in primary and first secondary, and the rationale for pseudoprogression and the reason adjudicated is better and should be the standard moving forward.
The conclusion statement will say DCVAx®?-L is safe, well-tolerated, feasible to deliver and effective and therefore should be considered the new Standard of Care for GBM.
Liked you on Twitter, Bright Boy
If they charge anything less than $300k in the US, then I will have a problem with management. It is a rare disease, they can get much more if they try.
ChiU, I used to have time for more contemplative music, but these days I need the quick punch. I look forward to be able to relax and absorb more. I don’t know any artists in your genre but have listened and enjoy.
My contemplative tastes have been John Ambercrombe, Herbie Hancock, Pharaoh Sanders, of course Miles & Coltrane and some other jazz greats.
That time will come again soon, and I can exit this rat race that is taking years off my life from stress. A favorite industry buzz word URGENCY which translates into employees being overworked and under appreciated.
I know many here love to perpetuate the theme that management lies, lies and only lies. Other than creating FOMO(i.e., September 12, 2020) I don’t recall anything unfactual. People interpreted statements incorrectly but lies, I just haven’t seen them. Predictions of future truths, now that I have seen. So when Les tells me ther are 100s of Millions of counterfeit shares after hiring Cofer Black to investigate, I believe him.
Sure, I totally agree and they don’t have a requirement or duty to announce a submission. It is hard to argue that the transparency would help or lack there of hurts shareprice given that literally every piece od positive news has been met with a drop in price.