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Thanks... yes... that timeline is in keeping with what the MHRA cites their 150 pathway to be.
And it's entirely possible that the timeline gets sped up. But if it doesn't, I'm hoping not to see the company get blamed (as per usual) for not adhering to the sped up timeline that others have suggested is what's really happening.
Yet Ex always spoke rather glowingly of Novocure.
It is not my understanding that they are already in a rolling review with the MHRA... despite the fact that they are implementing modules to submit their application (which is confusing, I know). Perhaps they've filled out the modules that are used in a rolling review, but the modules are not analyzed by MHRA until the application is actually officially submitted.
As I understand it (and IMO, the PR backs me up on this in stating that they anticipate "submitting the MAA in approximately the next 30 -45 days" and that they plan to "request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K."
And so that's why I repeat that it would take another 150 days (or business days, as the PR indicated, but the MHRA site does not), plus a potential clock-off, from when they actually submit the application in approximately 30 to 45 days.
That said, do I think that MHRA approval could come sooner? Yes, I think it's possible that it does. At least once it hits MHRA, it's in their hands and out of Northwest Bio's, who have proven themselves to be so notoriously slow in everything due to pursuing absolute perfection, that's it's almost (but not quite) to the point of being its enemy.
The company itself indicated they’re applying for a 150 day pathway made up of two phases, and that pathway indicates there is a possible clock off of 60 days (when necessary) after the first 80 days, known as Phase 1. If there is a clock off, it starts again after 60 days to begin Phase 2.
So the company is has laid it out clearly. If the process takes less time, that will be great. But I’m certainly not presenting any wiggle room that the company hasn’t already indicated themselves.
Were you hoping for a faster approval? I’m not saying it’s not possible… but my post was just trying to present the realistic timeline that the company itself had indicated.
Well what ultimately matters is that DCVax is approved on this first application (that as I recall, your narrative was that they’d never submit); it would be great for patients if it were sooner, but if it takes 150 days, or there’s a clock off making it take a bit longer, so be it. They’ll have the funds, or be able to raise them, to get there.
Now if DCVax-L does receive MHRA approval, what will your message be then? That it’ll never receive FDA approval? Will your narrative just continually push a negative note, or will you throw in the towel and move to a more positive one?
Just 22 informing posts today and 25 yesterday.
He trained at UCLA.. lucky! :)
Whew! Try reading that out loud and not taking a breath until you come to a period... great post, though. Very positive, with a lot of excellent points noted in that single sentence. :)
If you respect the word of this neurologist, Mark Malkin, out of the Cleveland Clinic, then perhaps you might consider respecting the word of these 66 non affiliated neurosurgeons and neuro-oncologists that I've listed below from these other highly respected medical centers who found the overall survival results of the DCVax-L P3 trial to be clinically meaningful and statistically significant in newly diagnosed and recurrent GBM.
Linda M. Liau, MD, PhD1; Keyoumars Ashkan, MD, FRCP, FRCS2; Steven Brem, MD3; Jian L. Campian, MD, PhD4; John E. Trusheim, MD5; Fabio M. Iwamoto, MD6,7; David D. Tran, MD, PhD8; George Ansstas, MD9; Charles S. Cobbs, MD10; Jason A. Heth, MD11; Michael E. Salacz, MD12; Stacy D’Andre, MD13; Robert D. Aiken, MD14; Yaron A. Moshel, MD, PhD14; Joo Y. Nam, MD15; Clement P. Pillainayagam, MD16; Stephanie A. Wagner, MD17; Kevin A. Walter, MD18; Rekha Chaudhary, MD19; Samuel A. Goldlust, MD20; Ian Y. Lee, MD21; Daniela A. Bota, MD, PhD22; Heinrich Elinzano, MD23; Jai Grewal, MD24; Kevin Lillehei, MD25; Tom Mikkelsen, MD, FRCPC21; Tobias Walbert, MD21; Steven Abram, MD26; Andrew J. Brenner, MD, PhD27; Matthew G. Ewend, MD28; Simon Khagi, MD29; Darren S. Lovick, MD30; Jana Portnow, MD31; Lyndon Kim, MD32; William G. Loudon, MD33; Nina L. Martinez, MD34; Reid C. Thompson, MD35; David E. Avigan, MD36; Karen L. Fink, MD, PhD37; Francois J. Geoffroy, MD38; Pierre Giglio, MD39; Oleg Gligich, MD40; Dietmar Krex, MD41; Scott M. Lindhorst, MD42; Jose Lutzky, MD43; Hans-Jörg Meisel, MD, PhD44; Minou Nadji-Ohl, MD45; Lhagva Sanchin, MD44; Andrew Sloan, MD46; Lynne P. Taylor, MD47; Julian K. Wu, MD47; Erin M. Dunbar, MD48; Arnold B. Etame, MD, PhD49; Santosh Kesari, MD, PhD50; David Mathieu, MD51; David E. Piccioni, MD, PhD52; David S. Baskin, MD53; Michel Lacroix, MD54; Sven-Axel May, MD55; Pamela Z. New, MD56; Timothy J. Pluard, MD57; Steven A. Toms, MD58; Victor Tse, MD59; Scott Peak, MD59; John L. Villano, MD, PhD60; James D. Battiste, MD, PhD61; Paul J. Mulholland, MD62; Michael L. Pearlman, MD63; Kevin Petrecca, MD, PhD64; Michael Schulder, MD65; Robert M. Prins, PhD66
1Department of Neurosurgery, University of California, Los Angeles
2King’s College Hospital, London, United Kingdom
3Department of Neurosurgery, Penn Brain Tumor Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia
4Division of Neurology, Washington University School of Medicine in St Louis, St Louis, Missouri
5Givens Brain Tumor Center, Abbott Northwestern Hospital, Minneapolis, Minnesota
6Columbia University Irving Medical Center, New York, New York
7New York-Presbyterian Hospital, New York, New York
8Preston A. Wells, Jr. Center for Brain Tumor Therapy, Division of Neuro-Oncology, Lillian S. Wells Department of Neurosurgery, University of Florida College of Medicine, Gainesville
9Department of Neurological Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri
10Ben and Catherine Ivy Center for Advanced Brain Tumor Treatment, Swedish Medical Center, Seattle, Washington
11Taubman Medical Center, University of Michigan, Ann Arbor
12Neuro-Oncology Program, Rutgers Cancer Institute of New Jersey, New Brunswick
13Sutter Health, Sacramento, California
14Glasser Brain Tumor Center, Atlantic Healthcare, Summit, New Jersey
15Department of Neurological Sciences, Rush Medical College, Chicago, Illinois
16Department of Neurology, The Ohio State University, Columbus
17The Cancer Center of Columbus Regional Health, Columbus, Indiana
18University of Rochester, Rochester, New York
19University of Cincinnati, Cincinnati, Ohio
20John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey
21Department of Neurosurgery, Henry Ford Health System, Detroit, Michigan
22Department of Neurology and Chao Family Comprehensive Cancer Center, University of California, Irvine
23Rhode Island Hospital, Providence
24Long Island Brain Tumor Center at NSPC, Lake Success, New York
25Department of Neurosurgery, University of Colorado Health Sciences Center, Boulder
26Ascension St Thomas Brain and Spine Tumor Center, Howell Allen Clinic, Nashville, Tennessee
27Mays Cancer Center at UT Health San Antonio, San Antonio, Texas
28Department of Neurosurgery, UNC School of Medicine and UNC Health, Chapel Hill, North Carolina
29The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
30Advent Health, Kansas City, Kansas
31Department of Medical Oncology & Therapeutics Research, City of Hope, Duarte, California
32Division of Neuro-Oncology, Icahn School of Medicine at Mount Sinai, New York, New York
33Saint Joseph’s Hospital, Orange, California
34Jefferson Hospital for Neurosciences, Jefferson University, Philadelphia, Pennsylvania
35Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
36Beth Israel Deaconess Medical Center, Harvard Medical School, Cambridge, Massachusetts
37Baylor Scott & White Neuro-Oncology Associates, Dallas, Texas
38Illinois Cancer Care, Galesburg, Peoria
39Medical University of South Carolina Neurosciences, Charleston
40Mount Sinai Medical Center, Miami Beach, Florida
41Uniklinikum Dresden, Dresden, Germany
42Hollings Cancer Center, Medical University of South Carolina, Charleston
43Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida
44BG Klinikum Bergmannstrost, Halle, Germany
45Neurochirurgie Katharinenhospital, Klinikum der Landeshauptstadt Stuttgart, Stuttgart, Germany
46Seidman Cancer Center, University Hospitals–Cleveland Medical Center, Cleveland, Ohio
47Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts
48Piedmont Physicians Neuro-Oncology, Piedmont Brain Tumor Center, Atlanta, Georgia
49Department of Neuro-Oncology, Moffitt Cancer Center
50Pacific Neurosciences Institute and Saint John’s Cancer Institute, Santa Monica, California
51Centre de Recherche du CHUS, Université de Sherbrooke, Sherbrooke, Quebec, Canada
52UC San Diego Moore’s Cancer Center, La Jolla, California
53Department of Neurosurgery, Houston Methodist Hospital, Houston, Texas
54Geisinger Neuroscience Institute, Danville, Pennsylvania
55Klinik für Neurochirurgie, Chemnitz, Germany
56Baptist Health System, San Antonio, Texas
57Saint Luke’s Cancer Institute, Kansas City, Missouri
58Departments of Neurosurgery and Medicine, The Warren Alpert Medical School of Brown University, Providence, Rhode Island
59Kaiser Permanente, Redwood City, California
60University of Kentucky Markey Cancer Center, Department of Medicine, Neurosurgery, and Neurology, University of Kentucky, Lexington
61Oklahoma University Health Science Center, Oklahoma City
62University College London Hospitals, London, United Kingdom
63Blue Sky Neurology/Neuro-Oncology, Englewood, California
64Department of Neurology and Neurosurgery, Montreal Neurological Institute-Hospital, McGill University, Montreal, Quebec, Canada
65Department of Neurosurgery, Zucker School of Medicine at Hofstra/Northwell, Uniondale, New York
66University of California, Los Angeles
Note: Dr. Mark Malkin obviously had enough respect for Al Musella and his knowledge on the subject of brain cancer that he chose to spend his time doing an rather lengthy interview with him, as have many other neuro-surgeons and neuro-oncologists.
I think about the same of his comments as Al Musella did.
The article also states,
To be fair, I'm not sure if what the CHM does is the assessment. They are an advisory public body, and they advise the ministers on the safety, efficacy and quality of medicinal products. Or does the "assessment" mean it's done by the MHRA. And as you point out, what is the point of the CHM meeting in December, if the MHRA could potentially approve DCVax in December? For my part, I wouldn't count on that, although it could be possible, so I wouldn't count it out.
We know that the company is requesting the 150 day application. It's possible that they could be given a faster pathway, but that is what the company is requesting. So if that's the final pathway (I'd hoped for the 100 day path), there is also the potential for the up to 60 day clock off in the middle of those 150 days in the event that the MHRA sees the need for it. And if so, that'll add some time to the 150 days.
I think it's exciting that we're finally arriving at a point where we can actually count down to what I think is a highly potential approval, but I don't think we should be counting our chickens before the eggs have even been laid. :)
Oh brother.
The first DC vaccine to reach the market was actually Dendreon, but they were unprepared for manufacturing. Lessons that I’m sure LP noted and adjusted for. So in a sense, does that make NWBO the second mouse?
Thank goodness that after years and years of DD in this stock, we finally have you here to explain what’s really happening here for all for us.
Great points! :)
Me too. :)
Speaking of songs... that September 25 submission date is looking even more possible.
The point is that with DCVax, and in the immortal words of Linda Liau, you get to "live longer". :)
Excellent, helpful explanation. :)
I thought that the Pfizer COVID shots had to be cyrofrozen until thawed.. so wouldn’t the pharmacies already have to have the capacity to store a DCVax-L vaccine?
The leukaphersis is a pretty long process (hours), so I doubt it.
That said, I could see them doing the DCVax shot in a Walgreens, but would they be able to cold store it and then thaw it properly? Each one of those shots is worth say $15k… so any mismanagement, or even accidentally administering someone else’s intended DCVax shot could be a real problem.
Just in time for my birthday! But I’m doubting it happens thus month, and am somewhat hopeful it happens by next month’s deadline. :)
ATL you are correct in stating that the MTD indicates Ray Tancredi had indicated at the Summit he spoke at that “he anticipated DCVax was in the pipeline to receive approval near term”; however, her point was to indicate that even with people such as him publicly bullish about DCVax-L’s prospects, the share price has been hammered.
But Ray Tancredi would not know the status of the regulatory submissions for DCVax-L.
What longs do know that read the official filings and company PRs is that the company is close to FILING an application for marketing approval. And the company has also specified the order of those applications.
The 2020 “K”covers the entire year’s events; and the SAP was finalized sometime prior to data lock in 2020.
True… although 250 of them were deemed rapid or psPD at baseline post chemo due to chemo/radiation and so would have had their vaccine made for them; and so many from that set would have been given the vaccine and are in the expanded access protocol (EAP) trial.
I thought September leaves were replacing April flowers?
Gotcha… thanks for the explanation. At this time, I believe the company intends the total price to be BOTH $150k in the US and £150 pounds in the UK.
And there’s been talk about billing it out more in sets … such as charging for the first four at once, and then billing for each of the scheduled vaccines as they follow.
I think they’re billing something like that in the UK at this time.
Another date to consider is September 25, which is the submission date that aligns with the December 21and 22 Commission on Human Medicines (CHM) advisory meeting.
Thank you for sharing your comprehensive DD in this post. :)
The use of PFS as an endpoint in the DCVax-L trial was intended to be used as a surrogate for the OS endpoint. The protocol intended that a successful PFS outcome for patients would be used to request Accelerated Approval, and that OS would be the confirmatory endpoint, meaning it would backup what the surrogate had predicted. PFS was never intended, as described in the protocol for this trial, as a stand alone endpoint. And so when it was found that PFS was erroneously being called due to the older, less reliable determinants of progression as laid out in the protocol, PFS as an endpoint for the DCVax-L trial could no longer be counted on as a surrogate for OS. That is why it was decided to take the trial out to its confirmatory OS endpoint. They never requested AA using PFS, making that endpoint basically irrelevant, in this trial. Thus, the PFS endpoint in the DCVax-L trial was not, as you assert, “a stand alone measure” according to the protocol itself.
Thanks… good to know, and a useful feature. :)
So you consider it pumping when someone actually takes the time to patiently explain their position to you and why it doesn’t make sense for them to do what you’ve accused them of doing, while constantly and repeatedly bashing the stock and every long in it.
Hmmm… it’s seems no matter how logical someone is with their response, your message will circle back to the same ol’, same ol’.
If the strike price (exercise price) is $0.10, it would apply to both “strategies” equally, so one is still ahead with strategy no.1.