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Nemesis, as I’ve stated before, it seems your concern is that the company loaded up the trial with patients who, similarly to you, either had GBM that disappeared like a “fart in the wind” or really never even had GBM.
It seems that would have taken the cooperation of over a hundred physicians, either neuro-oncologists or neurosurgeons, spanning from the entire United States and to include both Germany and the UK, to enact such a plan. It would seem you suspect all of these physicians (and collateral staff) of knowingly enrolling such “carefully selected” patients into the DCVax-L in order that it would demonstrate better results than the typical GBM trials.
Hopefully you can see that would take some real conspiratorial action on the part of many parties, parties that typically deal with patients who basically die within a few years of their diagnosis, and whose entire careers are dedicated to finding a treatment that can help their patients live longer. What on earth would motivate these same doctors to instead help to get an expensive placebo pass muster by the regulators?
Regarding the extent of GBM resection, the location of the tumor, the stage of the GBM, and the age and general health of the patients enrolled in the DCVax-L trial… all of this information is available to the regulators, and to some degree, available to the general public in the JAMA article. And all of the patients enrolled in the trial received the standard of care TMZ chemo and radiation, and have enough tumor (as you apparently did not; hence, you could not be enrolled) to make at least five immunizations of the vaccine.
If you see yourself as the type of patient were “carefully selected” to enter into the DCVax-L trial, you couldn’t be more wrong. Again, you could not have been enrolled because without enough tumor material, no vaccine could even be made for you. So no patients such as you were ever enrolled in the DCVax-L trial.
So Nemesis... is it your thinking that some of the principal investigators put patients into the DCVax-L trial that did not really have GBM and that's why some of them lived so long? Please quit speaking in riddles and cite specifically what your concern is?
Nemesis… you didn’t have any tumor to make the vaccine. So there is no way Northwest could have put you in the trial nor made your vaccine.
Hence, your own long survival could never have counted towards the DcVax-L trial’s long tail (made up of patients that were ALL treated with a vaccine made from their own DCs and their own tumors).
I think more that he was not eligible (not enough, or no tumor to make the vaccine with).
As I’ve stated… I doubt very much that his story is made up.
It is indeed odd that he’s hanging out here as he is.
But I’m quite certain that he’s from and lives in the UK, and that, to some degree, what happened, happened. And that said, DCVax was never a part of his treatment regimen, so I don’t understand (at all) the animus towards Northwest.
My thinking is that some in the UK may not understand the malice either. And suggesting that investors sell stock in the company really should have no part in the discussion, IMO.
Thanks, nemesis. I know that your encouragement to your so-called favorites to buy more is because they’ve been rather rude to you.
My purchase in this stock are not based on my gut, but rather years of DD.
All that said, I truly do wish you the best and am sorry that things turned out as they did for you (possible misdiagnosis and problems with treatment). If you actually did have the beginnings of a GBM tumor (there were cells found in your biopsy?), then you were exceedingly lucky. If the cells were never really there, then that is unfortunate, but mistakes do happen,
Thanks for the clarification, ex. :)
The good majority of our investors are currently retail, not Wall Street.
And I’m sure those that show up are capable of asking tough questions.
Well unfortunately for him, he’s certainly been left holding the NVCR bag.
Yes… I did see that.
Does our application fall into the first category (type IA- national)?
Just because the two posters both use the word “mate” does not make them the same person.
Whoseleftholdingdabag has been a poster for a long time… claimed to have made a lot of money in something and that he would put his gains towards charity. Of course, he didn’t make much in gains here, and so he became disillusioned with Northwest’s stock and sold.
I thought whose left lived somewhere in Italy now, with his wife?
Why wouldn’t people be available in the summer? The ASMs are usually available to virtually attend via a call in number, so if you’re the type that is fortunate enough to vacation for 3 months in the summer, then you can still “tune in” from pretty much anywhere.
Next.
I do believe that you really were a patient of Kings and that the patient records were your’s. I’ve written that to you as well here on this board. So obviously I do believe that you live in the UK and that your patient experience has been a legitimate one.
What I don’t care for is your attempts to encourage shareholders to sell the stock based on your veiled claims that “something wicked this way comes.” You’ve been perfectly willing to share the intimate details of your diagnosis, so why would you then hide the details of exactly what you think is going on behind the scenes? You either know, or you don’t.
Lykiri has indicated in a more recent post (that I hadn’t read yet) that he thinks the process began on 1/24. So doesn’t 150 days (without a clock off) take us sometime into later June?
So perhaps we’ll have an MHRA answer before the ASM… and if there was an RFI given after the Q, perhaps instead they’ll be in clock off. I would think, then, that we’ll at least get an update of the application assessment (where it is in the process) by the company at the ASM.
Thanks for the clarification Lykiri… 1/24 makes more sense… or maybe I just like those lesser number of days better (lol).
Smitty, Northwest held their ASM in 2020 on April 18, 2020 (a Saturday).
Having been through a fair number of Northwest ASMs over the years, I believe that a fair number of them have been held on a Saturday.
https://www.sec.gov/Archives/edgar/data/1072379/000110465920039528/tm2013863-1_def14a.htm
Lykiri, as an aside, if you are correct and March 7 marked the confirmation that the company would be placed in the 150 day assessment pathway, it took MHRA almost 80 days to notify them of this… making the process more of a 230 day assessment, and that’s without a clock off.
Why can’t you write exactly what it is that you’re aware of?
You’re very willing to warn us of “something” that it is so crucial that we should “divest”from the stock, but are unwilling to tell us what that something is?
You’ve even posted copies of your medical records here… why stop there? Please share the details of exactly why you think it would be “prudent” that we should “divest”.
What are these “major concerns”?
Where are they being “examined”?
How are they being “examined”?
Who are the “parties” examining them?
I didn’t forget it… but thanks for the reminder. :)
The German treatment is NOT the same as DCVax-L as the German version is missing the patient’s tumor lysate… which is kinda key.
I think it takes about two weeks.
Dennis... I'm wondering if this particular pathway applies to the DCVax-L MAA as it is a new medicine, and not an established one. I certainly made a similar mistake here a few days ago in citing a link that only applied to the assessment of clinical trial timelines. You'll note that the opening paragraph on your first link indicates that the guidance for international recognition procedures pertains to initiating clinical trials and "established medicines".
Fascinating to see how many times you post each day while not paying anything, or presumably being invested in any way.
Ugh… I missed that. :)
I was referencing the deep cleaning mentioned in the Q, not the inspection. :)
You could very well be right... however, this passage from the MHRA does note that the submission of the application is validated on receipt, and that an acknowledgement letter will be sent to the person submitting the application. And then the passage additionally notes, that "[I]f the application is valid then the assessment period will begin. This starts from the date of receipt of the valid application."
This MHRA blog link is a bit old (dating back to 1/5/2017 - and the UK was still part of the European Union) but it's likely still fairly relevant in its advice regarding avoiding an RFI.
If they did one in December, and the Q implies that another is up and coming, then it sounds as if they perform these deep cleanings twice a year?
I find it interesting that you seem to think your sad little tale would fully stop the MHRA machinery from moving forward on a treatment application for which you were never even eligible.
How about instead, you call them? Then report back to us. :)
When the construction begins on the C-Suites, the Q indicated that the company would try to time that work "to take place as much as possible during periodic scheduled shutdowns of the existing clean rooms for deep cleaning and special maintenance which are required for GMP compliance." I'm not sure how often they periodically shutdown Advent for a deep cleaning, but I don't think it's a stretch to think that during that time, there would likely not be any regulatory inspections scheduled.
I'm thinking #2 is more representative... but I don't think it intended to hide anything, but perhaps just unfortunately sped over as time on the show is always limited; but perhaps there is some contemplation of a time, possibly in the Fall, when management could better speak to all of the events in the works right now that they currently can't talk about with investors or give detail to. If you look back at the transcript, that possibility fits rather nicely into what turned into a bit of a word salad. That's my thinking, anyway.
I’m thinking LG meant something else by his drop of the word “fall” in that word salad.
Looking today at LessIsMore link to the UK’s gov site noting common issues: Validation cited [url]
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174398340&txt2find=receipt[/url][tag]here[/tag] where he states:
“And another one gone…” it would seem another one of the resident bears have gotten the boot… what is going on here? Will this “female power broker” return as herself (as did nemesis) or in another guise?
https://investorshub.advfn.com/boards/profile.aspx?user=840664
As I stated in the post you responded to, Linda Liau told me herself that the product is the same.
Just wondering… is it possible NICE marked your folder as “NUTS”?
If Northwest was not a trial sponsor, then it’s unlikely they could use the DCVax-L name. That’s certainly the case wth the other trial at UCLA using Keytruda, poly ICLC, and an autologous DC vaccine.
Still, please note, Linda Liau told me to my face at an event where I had a chance to speak with her for about 5 minutes that their autologous DC vaccine is exactly DCVax-L. So the question that remains is if you believe me on that last point, or instead, do you believe LL?