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COLLABORATION DISCUSSIONS: June 29, 2024 FLASHBACK.
Linda Powers, CEO
Incorrect.
LP has not confirmed no evidence submission has been made.
You now seem to change your focus.
Read:
Because I knew you wouldn’t read it right.
I don’t understand. How can share trading volume predict MHRA decision timing, Court decision timing or Flaskwork’s delivery timing? You really don’t make sense on this one.
In “exceptional circumstances” NICE can designate a candidate for CDF before STA evidence submission is completed, such as at the “scoping” stage of a single technology appraisal.
It also seems like a blatant violation of the ftca, because it gives one party trading advantages (like being able to secure a trade at a lower cost.)
Example. You can’t get it for .3002 and you must pay .301, but a market maker can get it for .3002 and sell it to you for .301.
Clawing that back would put offending brokers/mm out of business. Too bad.
I had ChatGPT take a look at the PDF.
She did not say (at the ASM on June 29, 2024) that she has not submitted an evidence submission, and even if she hasn’t by or after the ASM, NICE can designate CDF prior to evidence submission in “exceptional circumstances.”
Note: To my knowledge the last time NICE confirmed no evidence submission yet was on May 29, 2024.
On CDF possibility. Instead, LP told you more than you thought at the June 2024 ASM. She discussed future “health economics modeling” for NICE. To me that means they are much further along than you suspect.
https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisal-guidance/cancer-drugs-fund/data-collection-specification.pdf
Here are a couple important passages.
I prefer whatever ends up being best for patients. Of course, investors/company following that.
What was very clear, unlike some articles in past cases, is that the quoted amount is for DCVax-l therapy, not the SOC therapy surgery/chemo-radition that comes first with nGBM.
So 150,000 pounds aka 200,000 dollars seems to be an accurate figure solely for DCVax-l at this time.
One thing to note, Merck owns Temodar and Keytruda. If it owned DCVAx (NWBO) and Poly-Iclc (Oncovir), it could not only take advantage of EDEN price reduction, but it could likely package deal the therapies with countries, and of course Temodar is looking less and less helpful and probably won’t be used when Keytruda/DCVax/Poly-iclc used.
Yes. I think Stephen Webb will get to his fund raising goal soon, but it shouldn’t take GoFundme anymore. I’m hoping the CDF will soon kick in for future patients.
I donated, and yet there are many people who can’t rely on Gofundme or are not the most popular staff member where they work or known by large numbers of their community.
God bless everyone.
I encourage you to use the link I gave. Thanks. Just so you know, MHRA usually publicly announces first out of protocol and due to their transparency rules.
Thanks.
150,000 pounds = approx 200,000 dollars.
MHRA typically announces approval first, and sometimes a company will announce at the same time.
Here is a link to check….frequently or occasionally.
https://www.gov.uk/search/all?keywords=marketing+authorization&level_one_taxon=8124ead8-8ebc-4faf-88ad-dd5cbcc92ba8&level_two_taxon=cebc01ee-f70a-4397-a552-622e10b62508&content_purpose_supergroup%5B%5D=news_and_communications&public_timestamp%5Bfrom%5D=1/1/2024&order=updated-newest
Vertex, unlike NWBO, took two tries to get validated with their MAA (Marketing Authorization Application). Vertex’s first submission faced some issues, leading to a rejection, but the second attempt was successful (February 2023) in obtaining the required validation for their product. So much for ILAP*.
NWBO got it right the first time.
BTW:
*The MHRA (Medicines and Healthcare products Regulatory Agency) decided to discontinue the ILAP (Innovative Licensing and Access Pathway) program. This decision was made as part of a broader review of the regulatory framework to ensure that it meets the needs of patients and the healthcare system effectively. The ILAP was initially designed to expedite access to innovative medicines, but the MHRA concluded that its objectives could be better achieved through other regulatory mechanisms.
Note: The MHRA officially discontinued the ILAP (Innovative Licensing and Access Pathway) in December 2022.
In my mind, the reason mhra has been decreasing (aka speeding up) approval times is due to their international recognition program plus the trickle down impact on maa decision timelines for non international recognition routs — like DCVax-l.
The fact that (Vertex) CRSPR maa was validated last year in early February and approved in November bodes very well for the DCVax-l maa.
We were validated sooner in a calendar year — aka January 24 (versus February 2023)— we are not as big of an maa filing, nor is DCVax-l technology complex like CRSPR and DCVax-l is far safer. MHRA have also been observing DCVax-l at work in the UK for over ten years.
Not surprised Advent was recently licensed for human MIA.
To me, all the factors mean we are closer than some think.
Why does it feel like Sharpie will be first with reporting an important news flash again. He’s been on it.
It is interesting that:
93 (See RRH post) days from June 14 (most recent) motion = Sept 15
And
237 (average for mhra) days from January 24 (validation) = Sept 17
Because he wasn’t pumping and believes NWBO can help fight cancer. 🙂
🤦
Like I said, you’re out of ideas.
Gee, that’s funny, because Michael Bigger just reposted a tweet about the human MIA being granted. He seems all in on NWBO. Guess you’re all out of ideas.
https://x.com/biggercapital
You may have pushed the ignored enabled button. If you push the button again, you should see more posts. The customize button to the bottom right corner of the price graph at the top of the page opens that up.
The timing is interesting. 🧐 Seriously, I’ve tested the moderator request two or three times for over a decade and no response, but now….
Apparently they made me moderator from being in the Que years ago. I was testing it. I tested it early on. Many years ago as well.
Thanks RRH.
Who made me a moderator? I did not request this.
In that 64 patient Survax non-randomized trial phase IIa trial, for nGBM, 13% of enrolled patients did not have GBM, and they enrolled more mgmt methylated than unmethylated. Their graphs readily show these two factors alone very much account for their combined survival results of median 25 months.
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9995096/)
They have many years in front of them before they’ll complete their phase iii trial. It won’t be loaded with idh1 mutant (aka nongbm) and overloaded with methylated mgmt
Unmethylated performs worst, but Survax overloaded their phase II with methylated. Survax also included 13% IDH1 mutant patients without GBM in their trial, and these are a prognostic group with much longer survival. These selections explain how Survax justified a phase iii trial. Not a promising vote of confidence. Their phase iii won’t do this, and their trial will take many years.
That’s not the bet, and public information on Dr. Duffy is already available. You simply don’t believe it.
You’ll need to laugh to yourself after December 31, 2024. It’s a small combo trial.
In other words, your going to delete me every time I respond to this post.
Clearly you are not brave enough to take the bet, even though you are telling everyone no approval until 2025.
Coward, I don’t make money from posting. Accept my bet.
No, you already have the same bet with someone else, and I suspect you’ll be relived when you lose, as it will allow you to go long.
Coward, we did not enter any bet with no posting as a consequence. Accept my bet.
Your post won’t age well, but you know that, and it’s why you did not bet on it, imo. I’ll take the approval bet against you specifically that I will not post if no approval by December 31, 2024, as long as you agree not to post if approval occurs before January 1, 2025.