lindas have a posse
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Management cannot simply lie about the reason for filing 10K-NT unless they want jailtime before imminent MHRA approval. Seems like a bad risk reward tradeoff unless you're a psychopath.
Delay filed:
Monte Carlo simulations are used in risk models to forecast future returns from various business decisions. It's a very common model used in finance. I suspect they sold some derivative at a price based upon simulation which may now not be entirely accurate perhaps due to a change in inputs to the simulation. It will be very interesting to see the upcoming 10K in next 15 days.
https://en.m.wikipedia.org/wiki/Monte_Carlo_method
Very good point. There are numerous benefits brought by Flaskworks. I hope for approval by June after MAA approved in March - April.
Forbes are garbage. The only topic for Glioblastoma should be DCVax. The journalist who wrote this arficle is a blind jackass wondering in the woods.
Combination trial useless without Flaskworks?
DCVax has achieved 98% purity with the traditional clean room process as Dr Bosch explained in his manufacturing talk at ASCO.
Another day closer to approval.
Shorts, beware the Ides of March!
I agree which is why I have the idiots on ignore.
As we know Sawston passed inspection multiple times. Linda Powers runs a tight ship. I agree there likey won't be an RFI. Many who say the opposite forgot the company’s record of delivering results, are unfamiliar with the approval process, or wish to manipulate the stock price.
No RFI then MHRA makes determination on approval. No Phase II.
Phase II exists to address issues raised in the RFI.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173934572
In my opinion NWBO submitted a complete application without error while the exemplary data speaks for itself.
Regulators have known about DCVax for over a decade.
It was approved for use on children after approval in adults.
MHRA approved its commercial manufacturing as well as export.
No side effects.
Treats orphan disease that kills MPs, the rich, poor, the young, and the elderly.
Universal fear of Glioblastoma.
Approval only in question among those without a brain!
JFC the database on this website is fucked.
Phase II is only for RFI. Those who say otherwise are wrong.
I agree the trials should begin as soon as possible.
They can use potency assays and proteomic analysis not another trial. I don't see this as being a big deal for the handful of patients that would be in PI/II trials. It didn't stop Merck from running trials with DCVax at UCLA.
Though perhaps you are correct and we may not get notice of licensing deals, partnership, or buyout until Flaskworks gets GMP approval in UK. Though I am skeptical as the value seems already apparent.
They can use potency assays and proteomic analysis not another trial. I don't see this as being a big deal for the handful of patients that would be in PI/II trial. Though perhaps you are correct and we may not get notice of licensing deals until Flaskworks gets GMP approval in UK. Though I am skeptical.
Advent can ramp up to 12000 patients a year with open clean room technology while Charles River Labs have expertise with manufacturing DCVax right now. Why would partners wait for GMP approval for Flaskworks when they're not likely to see instant off label use for DCVax against other unapproved indications? I would expect additional trials to begin with traditional clean rooms but we may have Flaskworks approval by Q3 which would increase Linda's leverage in negotiations. These are exciting times!
CRL and Advent are already GMP certified with existing clean room manufacturing. I do not think Northwest are waiting for Flaskworks. They need revenue as soon as possible. Patients need the treatment. NICE will reimburse up to 100K per QALY. Private insurance in US covers existing high cost oncology treatments. Flaskworks will be needed to meet global demand but isn't prerequisite for regulatory approval.
FDA submission seems around the corner given we have patient advocates organizing for FDA approval.
Looking forward to updates in 10K due this week.
GlassJoe is often wrong.
Phase II is optional and only needed if an RFI is issued.
DCVax approved in Phase 1. No optional RFI or CHM.
Approval March 2024.
No RFI.
No CHM.
MHRA has known about DCVax for 10 years.
No reason to delay treatment with no side effects on optional steps which are not necessary.
Beware the Ides of March all ye who hold NWBO short!
Flaskworks is 12X more productive than manual clean rooms but also smaller. So I believe Sawston will very likely have higher capacity than 144K patients per year.
I agree jfr!
Can you read my poker face?
Sale of the company requires shareholder approval. We are certainly being gaslit by shorts who want our shares.
Bought more today. Congratulations to all longs who have done the same over past few weeks!
Jackass
Roth IRA!
If you're not selling today then tomorrow only brings additional opportunity.
No doubt in my mind that organized crime of Sicilian and Russian heritage are involved in manipulating NWBO stock. The question remains how long will it take for Cofer Black to strike?
MHRA already approved DCVax when they approved PIP and MIA. You are full of 🐎 💩!
Lots of 🐎 💩 in your posts per usual.
Bureaucracy can move faster or slower than their standard operating procedures dictate given many variables like institutional capacity, resources, and priority.
Covid 19 vaccines and treatments were fast tracked by NICE.
I maintain NICE will issue their assessment concurrently with MAA approval.
Retail shareholders are not going to accept a buyout at $10. I will be there in person to argue against that at any shareholder meeting while I think many would agree to fight such a hostile takeover.
I believe management would reject such an insult. So the only way this horrible $10 deal would be considered could be through hostile bid.
Right after we win the European Combination Patent we hear nothing but doomsayers. It's gaslighting. They're not getting my shares while my GTC limit buy order remains ready to be filled.
In reality MHRA can refer our MAA to FDA, Health Canada, and EMA under Project Orbis while again NICE does not need to wait for MHRA to sign off on MAA before finalizing their recommendations which can be released concurrently with MAA approval.
The idea that bureaucrats, working for one government on a shared mission to address a terminal brain cancer which killed a prominent MP, are completely uncoordinated here on this matter is insane. I believe private insurance reimbursement in US will take much longer than NHS!
As of 2023 NICE told me:
In reality NHS will reimburse up to 100K per QALY for rare and orphan diseases. I expect NICE will reimburse DCVax at 150K though I would be happy with 80-100K for UK market.