Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
So LC is shorting NVCR.
Where’s Sojourner? GUANLB Monday?
I think mhra guidance is unnecessarily vague.
That said, I think if it’s valid without correction, it’s considered valid on receipt — as AI stated, but I’m too tired to go back and show why that’s not inconsistent with some uk.gov language.
That said, I believe the UK was late starting their evaluation clock. I believe it started January 24, 2024, after the MHRA belatedly (through no fault of NWBO) concluded the maa “passed validation.”
The “confirmation” of validation, on March 7, 2024, is not an event which causes delay in an earlier 150 day clock initiation according to ChatGPT. In other words, MHRA can walk and chew gum at the same time.
The late June timeline for the ASM is consistent with a 150 day clock that started on January 24, 2024 and ends late June, without any RFI apparently needed. This final paragraph I write is most speculative, but logical. Who would hold an ASM 1 to 60 days before a decision? Not me. Therefore, no RFI was likely requested, and the regulators will make their decision based upon an MAA that was perfectly edited at the time of submission. Seemingly a good sign for MHRA’s final decision. (As a side note, I believe NICE will have an appraisal decision ready by late June)
RRH is not Flipper.
No, I didn’t see it in NWBO’s filing. I’ll go check BP’s filings.
Listen to you….
Learning Curve May 10, 2024
I tried to pin down ChatGPT, and I think we finally saw eye to eye.
I can’t access it, but I wondered the other day if the Judge/majistrate might deny the 2nd motion to dismiss w/o needing to hear Ms. Posner’s response. Well, did he?
Dummkopf. That was a study on people selected from 24 different sites solely because they had already survived five years or more.
Here’s your homework. Stop posting.
In the end, I don’t think it matters if “ucla’s” autologous dc was manufactured exactly like the phase iii DCVax-l monotherapy trial, the point is that DCVax technology is licensed by NWBO, including the DC + poly trial. The point is poly-iclc helps DC therapy work better.
The point is, we have a license that gives us the privilege to commercialize. My guess, is that DCVax-l as it was made for the DCVax-l trial, is slightly better than the UCLA lab grade version for the dc + poly trial, and my guess is that the NWBO Eden version, which is better at selecting and collecting healthy and activated dendritic cells, while substantially the same as artisan DCVax-l, is slightly better/purer than artisan. My guess is that Eden’s DCVax-l + poly-iclc will provide even better results.
There was a white paper written a decade or so ago by the UK’s Royal Society, and in it, the author(s) foresaw immunotherapy manufacturing continuing to improve purity/selection during the decade or so of any given phase/1/2/3 trials for a particular immunotherapy, and they suggested to treat this like medicine trials treat dosing selection. Analogous. Aka: improving purity/selection is akin to titrating the best dose strength.
I kinda think EX and views opposite him are all missing the point.
Exwannabe, from the phase ii autologous dc + poly-iclc trial,
Oops. You can’t read. Instead,
“However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together” — clinical trials.gov
Oops. You can’t read. Instead,
“However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together” — clinical trials.gov
Typo: instead, poly-iclc
Correct. It comprises the best formulation. This careful study took over a decade to complete, safety was irrefutably proven, and the best formulation utilized poly-SCLC with DCVax-l.
I wish you and your family well.
I didn’t know you were overweight.
You’re dumber than a post, now you move onto reimbursement, which wasn’t discussed in the article at all, and you now wrongly profess that NICE has publicly rejected the current DCVax-l STA appraisal currently in front of them.
mRNA is also immunotherapy. That’s what the article was discussing dummkopf, and even their company states it’s years away. You’re an absolute clown to suggest DCVax-l is not available in the UK today. You’re an even greater clown to suggest the MHRA has rejected the DCVax-l MAA and that they decided to tell the world through the Daily Mail.
Get help.
Nixon’s war on Cancer not being renewed or funded by congress.
DCVax-l Cancer vaccines are already available in the UK through NWBO’s decade old compassionate program.
That article was discussing mRNA cancer vaccines, and the five year reference to the NIH provided by the Daily Mail was not attributed to a specific NIH individual.
I’ve not had you on ignore at any point. I bounce on and off using my ignore list feature. It speeds reading to have it on, but occasionally I check post titles when it is off. I’ll try turning it off when I anticipate not being on the board.
No, not in any real time sense, an RFI issued by the MHRA is not comparable to a Complete Response letter from the FDA.
If a company like NWBO received an RFI, it is a far more common occurrence than not. In the 150 day review process, it gives a company an additional 60* days of “clock-off” time to clear up any issues the MHRA may have encountered during their first 80 day review. (After which the remaining 70 day clock-on review resumes)
Contrast this with a complete response letter from the FDA, where a company must inform the public of real concerns found by the FDA, that can’t (typically) be remedied in a short time frame.
* (On rare occasions, clock-off time during the MHRA process may be extended by yet another 60 days to allow the company further time to respond)
10q Next Friday.
Flaskworks is moving forward to complete
validity tests for the commercial grade unit version and then once approved, to commercially manufacture and ultimately transition from commercial artisan manufacturing to commercial grade automated closed system manufacturing — aka: Eden.
The prodigy system admits it has “limited open handling.” They admit they use plastic bags at separation as well.
Eden does not use plastic bags.
NWBIO
Prodigy uses plastic bags and still has “limited open handling through the process.” Fail
Cacoon cannot handle dendritic adherent cells.
Cell shuttle does not handle dendritic cells.
In other words, you have no examples of patented commercial systems capable of making commercial dendritic cell therapies to treat cancer, and the example you gave of an adherent cell manufacturing system for trials admits its process has “minimal OPEN handling steps.”
Your example still uses plastic bags:
“Italy — the drug failed the confirmatory trial so was pulled.” Exwannabe
I see, so you have zero, not “many.”
Name a dendritic automated closed cell manufacturing system commercialized and making commercially approved dendritic therapies for cancer. Name the company and the model.
Looking at Doctor Liau’s comments over the years, and the four censors previously isolated in the noncrossovers, I suspect the noncrossovers from placebo did worse than any bear here believes, and I suspect those censors will be located and converted to early OS events. I think that long term follow up public dissemination will come on the heels of NICE valuation.
There is a point, whether or not an rfi came as one letter or a series of information requests, that the response is concluded. FYI: One of the new approaches by MHRA is to (try to) limit RFIs to one letter, which is why they now stress well pleaded MAAs must be initially submitted.
It’s dismal what spoofing pressure over the years forced NWBO to finance at and the types of loans obtained. Hopefully that spell will be shattered soon. Damages.
If we had an RFI, who here thinks NWBO already responded?
Exactly.
One doesn’t spend for commercial Eden facility expansion at this point and time unless one is confident in approval and the approaching need to ramp for further UK demand. IMO, it’s that simple.
Interesting grammatical tense selection.
Inquirig said:
For what it’s worth, while I still believe an MAA decision could come any day, studying the NICE STA timeline again, scribbling down external comments and events, and looking at the 150 day MHRA process (room for flexibility) over and over, I think FeMike might be closest with an end of June aspiration. While I don’t agree with him that's the best one could hope for, I do believe that’s somewhat more likely than anything earlier or later.
I do believe some potential intervening preceding events, publications or deals for instance, still have a chance to catch many off guard.
Stonkmaster, I noticed your countdown repeated itself around April 29th and 30th.
We are actually 134 days from submission, and everything else is a day different as well.
No criticism, just letting you know.