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Yeah, until I read the March 28 MHRA newsletter, I had no idea MHRA might beat NWBO to any announcement. Maybe I read it wrong.
??? “as the data is being presented to the FDA”
???
This is from the March 28, 2024 MHRA Newsletter.
Product approval announcements
We have continued work to publish announcements to coincide with the conclusion of regulatory assessments, delivering on a key objective as listed within our corporate plan to build public trust and understanding of our work.
These are issued simultaneously as outcomes are communicated to applicants, and we work in tandem with the company and across the health systems and health technology assessment bodies ahead of issuing press materials. Products we have recently communicated about include diagnostic tools for people with heart disease and prostate cancer; a treatment for ulcerative colitis that both NICE and the MHRA have simultaneously published their recommendations on, and a first anti-seizure medication to treat patients with rare epileptic seizure disorder.
Prior experience:
Laura Posner
Prior to joining the firm, Laura was appointed by the New Jersey Attorney General to serve as the Bureau Chief for the New Jersey Bureau of Securities – the top securities regulator in New Jersey. In that capacity, she was responsible for administrating and enforcing the New Jersey Uniform Securities Law and regulations thereunder, as well as managing and overseeing the employees who staff the Bureau of Securities. Cases prosecuted under Laura’s direction as Bureau Chief resulted in hundreds of millions of dollars in recoveries for New Jersey residents and more than 20 criminal convictions.
Stonkmaster has a question or FOI out to CHM. I doubt they’ll tell him anything.
With prior regulators.
I do believe NWBO and advent did everything humanly possible to line up matters and prepare so that an RFI would be less likely, or at least very small in scope.
I mean, it seemed like they were getting Apollo 11 ready.
It does not. At least not in any time window that matters. Imo.
Great. Have a good one.
ChatGPT
When a public company sues market makers over spoofing allegations, it is typically the responsibility of state authorities or regulatory bodies such as the Securities and Exchange Commission (SEC) or the Commodity Futures Trading Commission (CFTC) to investigate and take appropriate actions.
State authorities, such as state attorney generals, may also have jurisdiction over market manipulation cases within their respective states. These authorities have the power to investigate allegations, gather evidence, and potentially take legal action against market makers if they find evidence of wrongdoing.
The SEC and CFTC are federal regulatory agencies that oversee the securities and commodities markets, respectively. They have the authority to enforce regulations, investigate allegations of market manipulation, and impose penalties or sanctions on market participants found guilty of misconduct, including spoofing.
It is important to note that each case is unique, and the involvement of authorities may vary depending on the specific circumstances and jurisdictions involved. Allegations of spoofing against market makers are typically taken seriously by both state and federal authorities, who work to ensure the integrity and fairness of the financial markets.
That has nothing to do with what you asked and what I cited.
Chat GPT
Naked shorts refer to short positions where the trader sells shares without actually borrowing them. In some cases, naked shorts may need to borrow shares before they can cover their positions. This can happen if the broker requires the trader to have the shares in their account in order to close the position. However, it's important to note that naked short selling is generally prohibited or heavily regulated in many jurisdictions. The specific rules and requirements for covering naked shorts can vary depending on the regulations in place.
Today you didn’t deny being Michonne, and Michonne was Pyrr.
Pyrrhonian
Re: A deleted message
Saturday, 06/04/2016 8:41:24 AM
Lol awesome. I'm okay with you guys thinking I'm every new poster that ever takes an interest in NWBO. It makes for very funny reading. But if you want to know the truth, there aren't that many. Pyrrhonian, jmlogan (made to debate AVII), Michonne (made to debate stuff I temporarily agreed not to under my Pyrr handle), and finishedworks and egkainia are two yahoo handles I've had forever. It just depends on which email account I checked last before writing a YMB message. I don't even think about finished vs egkainia handles.
There ya go, that's all of em. As with NWBO, you can accept the truth, or you can create and hang on to innumerable fantasies instead.
Yeah, but I was Raven Seldon* on a different site, many years ago.
You are Pyrr, Michonne and inquirig on this site. In obvious violation of TOS.
(*Can’t wait for season 3)
Thanks for the riveting entomology, Michonne. 🙄
Mr. Junorama stating August.
I should have highlighted Dr. Ashkan’s work and effort as well. Perhaps I’ll redraft this in a few days.
I was talking about the DD that followed. It is a helpful reminder and reassuring.
How’d you two get back on the same page so fast? Great DD insights, btw.
Lest we forget. Dr. Coley’s advances were buried for well over half a century. Later, so were Ruth and John Graham’s lysate vaccine work for cervical cancer.
When we look back years from now regarding how doctors Liau, Prins (& UCLA researchers), along with NWBO’s Boynton, Bosch and CEO Powers kept DCVax technology from disappearing off the radar, I think some things will start to make more sense.
From starting with the safest, least aggressive, least threatening and broadest spectrum DC therapy, to Dr. Liau’s tireless continuing educational grand rounds and global conference appearances, to Dr. Bosch’s nearly annual updates at ASCO’s Industry Expert Theater, linking UCLA’s/NWBO’s /Advent’s/Flaskwork’s research breakthroughs/developments, and his unending patent expansion, to Dr. Prins (and other UCLA researchers), continually optimizing and documenting the foundational scientific basis for DCVax, to Linda Powers working with regulators and establishing a path to manufacturing scale up with Cognate, Advent and Flaskworks; these giants, plus many others, worked all this time to keep DCVax technology ** from suffering Dr. Coley’s and Doctors’ Graham’s works’ back-burner fate.
Watching history in real time, as an investor, is a roller coaster ride and a lesson in patience, but it has also been quite something to witness these pioneers, day in and day out, grabbing their lunch boxes and working to bring the world a beginning to the end of cancer.
(** Not to mention the future combination and DC advancements NWBO/UCLA are developing.)
I think there are rules against pure profit from compassionate care, but that would mean I’d have to look it up again. Then there is the trap of looking like you are marketing if you start booking sales. Then there would be less flexibility with working with poor and rich patients on a sliding scale before some other forms of reimbursement.
As I’ve been saying for a few years (or more), to me, they would have “say” if acquired as a wholly owned subsidiary.
I didn’t say she did. BTW, confident is spelled with an e.
Money can be extracted from lawsuits moving successfully through a process and increasing reward chances. Just saying, I’m hoping that does not play into regulatory timing.
I’m encouraged Ms. Posner asked that pleadings for the MTD conclude by early May, even though the judge ended up giving defendants a little more time. And that’s all I have to say about that.
U might check your math.
That’s not how it’s played. Watch the Deer Hunter. Or don’t. It’s gruesome. You couldn’t pay me to watch it again.
Allow me to suggest the following edits:
DCVAX-L MAA TRACKER
104 days from SUBMISSION
104 to 90 days from VALIDATION
Days to DECISION
0 to 60 days for 150 day assessment (no RFI)
61 to 120 days for 210 (150 + 60) day assessment (with RFI)
121 to 180 days for 270 (210 + 60) day assessment (with RFI)
BTW, the window is wider if clock off time (one to sixty days) occurs and/or validation confirmation didn’t happen until a couple weeks after submission. Still, I’m hoping things go much faster.
BTW, the MHRA approved DCVax-l for compassionate use about a decade ago. You are thinking about Sawston’s license to manufacture for compassionate, which happened about two years ago. Prior to that, it was made exclusively in London for compassionate.
My primary concern is that they not let the MM lawsuit somehow guide the regulatory timing, but I obviously have no say on that, and I hope they don’t either. I found it encouraging that Ms. Posner was asking for MTD pleadings to be done by early May, (even though the judge went to mid-June), I say without explanation.
I think the standard is lower there with compassionate, but I don’t disagree. Perhaps what is more telling is that LP finally pulled the trigger on submitting an MAA for regulatory inspection. LP would not have done that without minimizing risks from every conceivable angle and some level of educated assurances from former regulators who are consultants. IMO, even continuing trial maturation, which no one really thinks about anymore, likely buttresses DCVax-l’s prospects.
Wondering if we might see some PIP trial initiations soon and/or another NICE update.
It’s starting to look like, because time moves on, that Mike is probably right. Sawston will commercialize/initiate ahead of Eden, but others will commercialize when Eden is ready, and Sawston will then make the switch.
World peace would be nice.
It seems like the timing, by now, would have led everyone but Sawston planning to start with Eden, or whatever the commercial version will be called.
Not sure. The preprint is already out, but perhaps a final print means more to the scientific and investing community. Hard to know. You might ask someone like John Carroll at Endpoint News, even though I’m not a fan, he’d probably give you a fair read on that.
I think you meant narcissistic psychopaths. “Mentally ill” is too general and can include such common things as depression or anxiety.
Edit: rGBM
Car-T study: Ok, finally, by the way, the authors concede that the reason Car-T likely failed in that patient is that tumors 9, 10, 11, etc, did not have cancer cells with the antigen the car-t was targeting.
In other words, in one of the 75% GBM patients, in a 65 patient trial*, tumor escape occurred within 7.5 months of car-t treatment initiation, two months of which included a complete response (in five tumors) before treatment failure via tumor escape.
The cause of this tumor recurrence is currently under investigation, with preliminary results suggesting decreased expression of IL13Ra2 (Fig. S8 in the Supplementary Appendix).
Continued: Car-t case study article.
“They are counting tumor “stabilization” to extend their 7.5 month “dramatic” response claim.” flipper
During the six weekly intracavitary infusions (cycles 1 through 6) (Figure 1A), the treated tumor in the temporal–occipital region (tumor 1) remained stable for more than 45 days after surgery without evidence of disease progression (Figure 1B). However, MRI revealed that nonresected tumors in the left temporal lobe (tumors 4 and 5) and new tumors (tumors 6 and 7) near the resected lesions 2 and 3 were progressing (Figure 1B). In addition, new metastatic lesions in the spine causing leg numbness, including one large tumor that was 18 mm in diameter and several smaller tumors (=4 mm), were detected (Figure 2C, and Fig.