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Well, if the delay was for Eden, maybe they could have just stayed with CRL. They already have automated cell manufacturing systems from both Miltenyi Biothec and GE. Health.
https://www.criver.com/products-services/cell-and-gene-therapy-cdmo-solutions/cell-therapy-manufacturing/autologous-cell-therapy-manufacturing-services?region=3601
On the "worst CEO list", AF had M Shkreli one behind LP.
I think MS deserves number one. So have to disagree with AF on that.
Viagra.
Many forget exactly what M Shkreli got an orange jumpsuit for.
He had owned a hedge fund. The fund took over a public biotech. It used the cash raised through the public bio he controlled to fund his personal companies. He also created a huge pump/dump in the KBIO (or whatever the name was).
Can anybody think where else we have heard that story?
I have found no mention of the MHRA MAA submission time.
Takeda has disclosed the FDA submssion (March 2023, approved Nov 23), EMA submission (validated June 2023, approved June 2024) and the Japan submission (Sep 2023). Also the FDA review was under ORBIS so the MHRA and other Access RAs were sitting in on it.
FDA, EMA and Japan are the big 3 RAs. Both market value and that they are considered the leaders. That is why it is hard to hear much about submissions to others.
Articulate reply there DD.
BTW, are you still comfortable with your bet that MHRA approval wold happen by August 2024? From post 721109:
When the story shifts to future trials they need to set the new goalpopst to "soon".,
Expect the storyline shift as the days turn longer.
Well, Annie Post says it, so it must be true.
By Sep 28 either they announce approval or the MHRA had an issue and NWBO is appealing.
Thanks Anne.
So you are saying Dr Cloughesy,, the PI, does not know what he is talking about when he asserts the trial is not designed to establish efficacy?
Perhaps you can educate him on the subject.
They may well announce a combo trial in the next half year. They have announce many in the past after all (none of which launched). They might even launch one, though March might be a tough timeline for that.
But running a combo trial with Merck or such as a collaborator is not what people consider a "partnership" or "deal". And they do not bring in cash, just help to offset cost of trial.
There are literally hundreds of these combo CI trials with various small bios all over the map. Nobody cares much. Even NVCR has a couple:
EF-41/?KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (EF-41)
EF-36/?Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer (KEYNOTE B36)
That timing you are quoting is what happens after the CDF conditional funding has run its course and NICE needs to re-evaluate for a permanent decision. Read the start of section 4 of your PDF.
Yes, NICE needs an economic model for that appraisal. They also need an economic model for the initial appraisal. That is what is in the evidence submission.
Why did you just quote yourself instead of the actual NICE document that I quoted?
https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisal-guidance/cancer-drugs-fund/data-collection-specification.pdf
Regardless, it states clearly the company can signal potential use of the CDF. It is still up to the NICE appraisal committee to recommend it. And that requires an evidence submission.
That sucks. It can be really bad with options though.
BTW, just tried a test with Fidelity and they allowed .3033, so t is broker by broker.
It s a single click with no confirmation, so easy to do so by mistake.
Just send a message to admins to fix.
Can I accept?
Please?
Yes, that is a nice interview.
A few notes from it. Around 23:30 she is disusing the actual antigen used and is talking about purified specific antigens and getting away from lysates.
"So here, you take the blood cells and they pretty normal on the surface anyway, and you can culture them in GMCSFas a growth factor, and IL-4 for differentiation. and load them with purified forms of antigen, and this is getting away from the tumor lysate where you would loading them with tumor antigens that you know about and don;t know about, which is good, and IL-10 and tgf beta and all these negative regulators."
I.E., the multiple antigens is good, but comes at a cost of negative regulators in the lysate.
Not trying to say one approach is clearly better than another. Just that many experts in the field are not able to see what the scientists on this message board assert is obvious.
Oh, she also seams to support RNA based approaches.