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Seriously?🙃
GB, I assume you are getting your figures interpreting what Dr Bosch said differently than I have but if you are getting your numbers from someplace else, please reference. Reviewing Dr Bosch's presentation, I can only interpret it the way I've presented it.
I just listened to the relevant section of Dr Bosch's Presentation again. At min ~27.5, he states "Currently, in this facility we can manufacture up to 50 patients per month in 2 cleanrooms and this can be scaled up to 1000 patients per month". He would be talking apples and oranges if he was describing current capacity of 50 pts per the manual way and then descibing scaling it up to a 1000 pts using the Flaskworks system. But what sealed the deal for me is at min 30 where he begins a whole new section of the Presentation called "The Future - Process Automation" where he and then Murthy describe Flaskworks. At least that's the way I interpret it. The Presentation can be found here: https://virtualtrials.org/dcvax
The ASCO 2022 Dr Bosch slides showed ~ min 28, they already had capacity for 50 patients per 2 cleanrooms w a potential capacity of a 1000 patients per month. So 2 yrs later around the time of expected approval capacity can be way north of that. I'm sure they'll build out more manual rooms to make room for initial approval to meet expected demand and save some of the unused rooms for the Flaskworks system. So again, 1000/month which is 12,000 per year for potential manual production and if you automate that per the recent PR, you can get a up to 12x increase to 144,000.
George, is this a typo or I'm not following you
Catalent receives another regulatory wrist slap at Indiana plant included in Novo buyout
What's the word I'm looking for - Schadenfreude? nah, not quite the word I'm looking for but I am trying to remove a smirk from my face in reading that as part of this buyout, one of Catalent's plants has some very serious issues.
Right, they wouldn't be stuck starting w the artisan version, they could start w the automated system but they would need to confirm the 2 ways are equivalent/comparable before starting.
If they started treating patients today, it would be the manual method and that would be the case in the future until they confirm that the DCVax-L is comparable.
Novo Holdings Buys CDMO Catalent for $16.5B to Boost Semaglutide Supply
Whereas NWBO doesn't have to spend $16.5B to boost DCVax-L supply because we have our own dedicated CDMO in our pocket. That's a cost savings, me thinks.
https://www.biospace.com/article/novo-holdings-buys-cdmo-catalent-for-16-5b-to-boost-semaglutide-supply/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=292811519&_hsenc=p2ANqtz-_hnP6AX2_G5nDl80EFmBOtJYVLm6DtQu8ArW0s_73tPPIv_I7hSdoOEYcDr1vWymUjXlI05rHOYqsd7fJpypUPi8hEeQ&utm_content=292811519&utm_source=hs_email
Yeah, I was thinking of that thread as I'm reading the posts and PR today.
That's true regarding medical devices but the Flaskworks is not a medical device, it's part of the manufacturing process.
Good to hear from you ou. You're the one who alerted me to this board from a post on Yahoo many many, and sigh, many years ago.
Thanks Stonk. That does clear up things - bigly.
Regarding validation occuring from the get go, SOS comes to mind, and regarding validation occurring in early January, why not PR that and keep us updated. So I'm not sure about that.
Seems like freezing tumors is SOC in that neck of the woods. Good job Dr Ashkan!
Indeed, it does hit home! to a T
I don't know if you're saying it in jest
Ditto here.
Ya know, is this upcoming manufacturing inspection a slam dunk or what. All the MHRA inspectors are vying to do the inspection because it will be easy peasy from their end.
I suspect they just want to get the application across the finish line before implementing new changes. Although at times I thought they woud implement Flaskworks EDEN from the get go, I moved away from that thought after hearing at last year's ASM they were still working on optimization. Once the MAA is approved they can submit a major change, CBE30, or Change Being Affected in 30 days, where they submit to the RA the change they want to implement which the RA will need to approve or deny in 30 days. Note CBE30 is FDA parlance; I am not familiar w the MHRAs exact mechanism of approving these type of changes but I would think they would be somewhat similar.
Interesting: 2 different drugs/trials hit their primary PFS endpoint but the RAs want OS data before submitting BLAs.
Cabometyx, Tecentriq stave off prostate cancer progression as Exelixis joins Novartis on FDA's wait list
https://www.fiercepharma.com/pharma/cabometyx-and-tecentriq-stave-prostate-cancer-progression-exelixis-joins-novartis-fda-wait
What was DCVax-L P3 primary endpoint again? That's a rhetorical Q.
It's a big deal if your drug makes it into the NCCN Clinical Practice Guidelines.
IF this Principal Scientist, Discovery Pharmaceutical Sciences is lucky, he/she might be on a team that gets a pre-clinical candidate into the clinic in several years. And then in the clinic, it will have to progress thru Phase 1, 2 and 3 trials or some variation of that before they can submit an application to market it. It will take a long long time. The name NW Bio might be a distant memory by then.
Yeah, I didn't think that was you but you never know unless you ask.
Single Stock, there is an imposter (or not) masquerading (or not) as you, commenting on a NYTs article titled "These Seven Tech Stocks Are Driving the Market". The comment is nothing nefarious but I find somewhat funny that that there is more than 1 nom de plume named Single Stock
I believe that's what's going on. No reason not too.
It will be a moot concern once DCVax-l gets approval in GBM. On the other hand, I can see DCVax-l getting Tissue-agnostic approvals in other indications.
Musing #2: Another NWBO newsworthy event would be finding out they hired a sales/marketing lead and/or team. I think that would cause a positive ripple in the Force. We'd find that out via a PR or from someone like a DennisDave who checks Linked In every once in a while to discover these new hires. Logistic support would come from Advent via the Patient Coordinator and Liaison Officer et al type peeps
Ugh! but look at the bright side, maybe that can count as penance.
You'd know what would be a cool journal article and/or PR but more likely journal article - a paper supporting comparability studies on frozen leukapheresis material for DCVax-L manufacture. Why not NWBO, put it out there! You got to have it. OK, musing is over.
Edit - Sorry Chiugray, this wasn't meant for you.
Ha! A convert?
What!!! That is so wrong!!! Pfizer bought Warner-Lambert for Lipitor.
You can think of it in another way too. If they're garbage posts that posters ignore (me et al) or don't believe (everybody) and is still getting paid to post this trash some entity has a lot of cash burning thru its pockets from illicitly making money and it's just a cost of doing business; an expense on the accounting ledger.
There's no right or wrong just guesswork and a strong dose of wishful thinking.
I think of that March approval scenario also. The 80 day assessment is around March 9, and the CMC meeting is March 21 - 22. We can dream, can't we?
Wasn't it Larry Smith who mentioned 1.7M pp? That shocked everyone since LP right before that mentioned 1M pp at the ASM. I can't find where he said that but did find where aperture007 asked DI about it and DI had no idea where LS got that #. A million pp is more believable. Just one of those war stories that got bigger w time.
I'm assuming they're not proceeding under the 150 day route until they tell us. They requested to the MHRA to proceed under rapid review but unless they notify us they are, I can't assume that as per their Dec 21st PR which states