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Sawston and the MHRA sitting in a tree
K-I-S-S-I-N-G
First comes the MAA
then comes Approval
then comes CRL and the FDA in a baby carriage
I believe the slide is telling us that 1,000 patients for month is the maximum # of patients you can have processed using the manual method. I'm agreeing w what you are saying except "it would only take about"
The AA pathway has sailed a long long time ago for us. It's regular approval for us for DCVax-L GBM in the short term but might be helpful for future sBLAs.
An interesting hypothesis and if it stands the test of time it becomes a theory but looking good so far. However, let's throw a submission into that to revise the hypothesis..
You'd better be nice, some shorts/longs better not cry, Shelly the IH Admin is coming to town
That's funny although Pyrr came to mind w the changing of his stripes.
Occam's razor, yeah, I get that but w time on my hands musings occur in trying to reconcile in my head w my experience why it seems to be taking longer but of course adjuvant temo w DCVax is the most likely scenario of what will be in the BLA. I’ve helped review a successful BLA prior to submission albeit many years ago for a small bare bone strapped biotech and the BLA was more or less in its final form except for the clinical data while some secondary clinical data from one of the trials was still trickling in. And I understand what you’re saying about BP and resources snapping to attention because I worked there too. But I’ve seen what a small biotech can accomplish. Several differences w NWBO though is we had all key personnel working for the biotech under one roof with only a key person (Director, Manager) or two in each dept whereas NWBO doesn’t have any of those key people in house. I would believe that NWBO would be operating more like a normal biotech, if it didn’t have that short attack yrs ago w the share price tanking making financing more expensive. If Dr Bosch is making all the final decisions that the consultants provide for Clinical, Regulatory Affairs, Manufacturing, Quality, Medical, etc that normally are made by different dept heads in-house then I can see that being a bottleneck and might be somewhat overwhelming in making quick decisions causing key decisions taking longer. And off course, even though we were pushing through a biologic, NWBOs BLA is by far head and shoulders more complex too. As I said in the beginning of my posts – Musings but I still wouldn’t be that surprised if the label would be stand alone DCVax-L w/o adjuvant.
MAA delay musings; One speculation on the board is the MAA is being delayed to wait for the poly-ICLC trial to mature. But here is another speculation; I'm wondering if some of the delay is because they are trying to do away w adjuvant temo from the get go. Of course the P3 pts were given temo/adjuvant temo along w DCVax-L but looking at Dr Bosch's ASCO 2023 presentation, Compassionate Pt # 1 + 2 were not given adjuvant temo (pt #2 did receive initial temo but not adjuvant). Recurrent pts in the DCVax-L trial did not receive adjuvant temo and they had better results. I'm sure they have a bunch of RWE to make their case now. The Opinion posted today from DC vaccination for GBM patients; has a new milestone been reached? notes non temo better results too
1.03000.0000 (0.00%)
At close: July 31 04:00PM EDT
Delisting
SPPI is delisted effective Aug. 11, 2023
Wow hope4patients! This is really an excellent article. Even though they got skin in the game w their own trial(s?), they look at this objectively and conclude you need DCVax in the tool box. It knocks down many short arguments that are discussed ad nauseam on this board about the trial and the JAMA paper. They go over 7 concerns which you hear in 1 form or another discussed on this board. It feels like the DCVax-L army has been joined by another army in support. When reading the JAMA paper, one should read this opinion about the results.
This summer I went swimming
This summer I might have drowned
But I held my breath and I kicked my feet
And I moved my arms around
Moved my arms around
This summer I swam in the ocean
And I swam in a swimming pool
Salt my wounds, chlorined my eyes
I'm a self destructive fool
I'm a self destructive fool
This summer I did the back stroke
And you know that that's not all
I did the breast stroke and the butterfly
And the old Australian crawl
The old Australian crawl
This summer I swam in a public place
And a reservoir to boot
At the latter I was informal
At the former I wore my suit
I wore my swimming suit, yeah
This summer I did swan dives
And jack knives for you all
And once when you weren't looking
I did a cannonball
Did a cannonball
This summer I went swimming
This summer I might have drowned
But I held my breath and I kicked my feet
And I moved my arms around
Moved my arms around
Hey!
PS While skinny dipping.
We'll find out soon, or, in the next Q. Stay tuned!
Good Q Beartrap. We can only surmise.
The tide is coming in Hank! An insurmountable force before you know it.
Yeah, hopefully. Still a bit of a breadcrumb but we're getting closer. Much closer.
One notable change from the May 10K to this one:
May 10 Q
Really RobotDroid?
And expecting it to be approved for ndGBM and rGBM then the label will say "GBM".(Period). How cool is that?!!!
So you don't think it will be submitted relatively soon? You are welcome to your thoughts but we have a difference of opinion.
Thermo, the take home, for me, from your post is less about the timing of when they will submit and more about that they really really are in the process of getting to submit relatively ‘soon’.
It has taken them a seemingly long length of time from when we first started expecting topline data back in 2013 -2014 (that seems so funny now) to get to this point that waiting a little longer is almost irrelevant to our expectations for DCVax-L. I say a 'seemingly' long length of time because, in hindsight, this novel immunotherapy trial was leading in a paradigm shifting way via: the shift from PFS to OS endpoints, 5 year data vs 2 yr, old definitions of GBM (IDH1 analysis, etc), the unethicalness of randomized trials for diseases where the use of current therapy is a death sentence, the use of External Control Data, manufacturing, and heck, even the Good Documentation Practices standards changing from 10-15 yrs ago possible causing issues before they locked the data.
So knowing from your deeper insights in your discussions w management that they are very close to submitting the application i.e. that it really IS going to be submitted, is reassuring. Thx.
And that's it in a nutshell.
Bye Bye Spectrum Pharmaceuticals. I feel a little sad and thinking pozi should have got more respect than it did from the Agency. Per the 8K
Ok, I was going to take that poster off ignore just to confirm the claim. Now I don't need to do that.
Yada, yada, yada.
That was kind in just saying idiot. The word Asinine comes to mind.
BREAKTHROUGH, BREAKthrough, Breakthrough...Time keeps on slipping into the FUTURE (ok, Steve Miller came to mind)
The word's getting out there. In case anyone else was stumped by Dr Pearlman's affiliation w the Swedish Medical Center
You know what's interesting about this? They list NWBO and not Advent. One would think that Advent, the manufacturer and purchaser of these supplies, would be listed.
Edit - Thinking about it, I'm a little confused. Cedarlane is providing a list of companies who purchase from them. I think that would be confidential info. Normally, a company would have a supplier list of supplies they need from other companies which they would maintain and audit if needed and that mans NWBO provides them w a item of some sort. Idunno.
'The Beginning' of much more to come regarding clinical activity.
Well, it had me cracking up.
Will the Clinical Coordinator work hand in hand w the Patient Coordinator and Liaison Officer? Undoubtably,
So why would Advent look to hire a Clinical Coordinator? Advent, a CDMO, is a manufacturing operation and now they are going to go into clinical? Per their web site, Advent would not need a Clinical Coordinator.
I was just going to respond to your previous post after reading the ASM transcript and saw that you already responded. LP mentions up to 30 hrs
Doc, I don't think it would be 36 hrs of labor for each 'batch' i.e. individual's tumor processed. The QP might review the final data and review the Certificates of Analysis and Certificate of Conformance generated for each 'batch' or the QA dept might review the final data and the QP just reviews the CoA/CoC. The QA check of the final data to the CoA/CoC may take some time (a half day, a day?) if the QP does it all. Could I see 36 hrs? Well, maybe, I wouldn't be totally surprised. Anyhows, when you multiply 4, 8, or 36 hrs by 1000s and 10s of 1000s of patients per year as opposed to several batches of traditional drug that adds up to very considerable amount of time. I think you got that '36hrs' from somewhere, can you provide more info on that?
Abeta, it was a Phase 2b trial w results and they PR'd that a year or 2 ago. And every time I see that they indicate/PR they are starting a P3 trial I check CT to look for details but the trail is not listed. Weird because they've been saying they're going to start a P3 for the last few years now.
EDIt: I guess those 20 patients with seizures (42.6%) noted by pgsd plays into it.
Excellent point Doc logic - QP bottlenecks.
For a normal drug, you run several campaigns a year to make several batches and the QP would review and approve those several batches/year. With DCVax-L, you’ll have 1000s and tens of 1000s of batches per year; a potential bottleneck for sure.
Reminds me of the mushroom joke
"All mushrooms are edible, sometimes just once."