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Autumn Begins:
Sun, Sep 22, 2024, 8:43 AM EST
How could you possibly know there will be no MHRA news?
You can’t.
It’s that simple. You are giving an opinion.
Note: I don’t take issue with your first two full paragraphs, and although LG chose to fudge, I think there were likely good internal/scientific reasons for those delays.
This seems perfectly suited for a collaboration trial with DCVax-l and DCVax-Direct. TRINTELLIX goes generic in 2026. It is interesting Takeda manufactures it for the U. S. .
One more post this weekend. I don’t think people understand why I posted this. Look at the link and tell me how many countries you see in the consortium in addition to the UK? The program works in BOTH directions.
P.S. We have considerable IP filings in every one of those countries.
Australia: streamlinedsubmission@health.gov.au
Canada: HC.tpd.international-dpt.SC@canada.ca
Singapore: HSA_TP_Enquiry@hsa.gov.sg
Switzerland: Networking@swissmedic.ch
United Kingdom: access-mhra@mhra.gov.uk
https://www.tga.gov.au/access-consortium-new-active-substance-nas-work-sharing-initiative
🍁See you all in Fall!🍂
You won’t be posting in February 2025.
It appears NWBO received accelerated review and are on track for a decision by early Autumn.
Your statement below will not age well.
£151,349 raised of £150,000 goal!
Fruquintinib approved to treat adult patients with metastatic colorectal cancer
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 September, approved the new medicine fruquintinib (Fruzaqla) to treat adult patients with metastatic colorectal cancer (CRC).
This product was submitted and approved via a National procedure, as part of an Access Consortium New Active Substance Work-Sharing Initiative.
I looked that initiative up. Here it is.
https://www.tga.gov.au/access-consortium-new-active-substance-nas-work-sharing-initiative
Already been mentioned and discussed.
Doesn’t really matter what bets have been made. After you lose, you guys have created new profiles that are already at work by stating they (aka the “new” bears) thought approval would happen but management would still blah blah blah.
Retrenching bears.
Accurate.
Not exactly. Those were on the clock day averages. Which means you’d add another 60 days if you used averages. (Besides, we are most likely looking at an accelerated review)
I don't think you use averages here.
Senti is seldom wrong on stuff like this, and the March 7 rumor she heard, or whatever it was, currently fits today’s situation better than January 24 clock start. Why the clock start was delayed is apparently on MHRA, because as NWBO has pointed out, their validation went through without any errors by NWBO and its contractors.
In fact, that August 2 8k reaching back “several days” also touched on the aspect that inspections were ALREADY planned. This would mean no hiccups by either side after clock start up to that point.
Still to your point, we are in the window regardless. NWBO did everything it could to make the review accelerated to 150 days clock on, and apparently, they also completed their clock off time in 60 days, if you use March 7 as the original starting point.
If we go back to how much preparation was made before and after the maa filing, it appears, knock on wood, that the actual review time hasn’t missed a beat if you use March 7 as your start date.
One can hope we have now moved ahead of schedule, but that’s just optimism.
By better fit, here’s what I mean.
March 7 + 80 days + 60 days = July 25.
On August 2 there was an 8k stating inspections had already been scheduled, and the way it was written, “several days” could essentially account back to July 25. That doesn’t take much imagination to subtract a week.
As Senti pointed out, add another 70 days and you get October 3. Don’t like the week subtraction? Call it October 10.
Yeah. Senti’s noise would have been a bombshell a month ago, but now it’s just a slightly closer fit. Regardless, we are in the window.
Once it became apparent the biologic development process would take longer, NWBO found a major financier and a lot of real estate in Sawston, plus a top regulator that allows compassionate care programs and was/is more adaptable to ECA. The UK is also a reasonable sized region for an initial launch.
Good question. It makes no sense, and as a bonus, NWBO used esp to make it known which validation date started the clock. It does not match what the MHRA emailed to a poster (sparky?) here.
Edit: “I’m not stating that’s the reason, but it could be a factor. If NICE sets a low price first, then it becomes more difficult to justify a higher price later within the U.S. (FDA jurisdiction).”
You seem more interested than anyone else, shouldn’t you be updating us?
Let me add one to this post from yesterday.
So maybe I’m too simplistic, but here’s how I see getting the pps up close enough to BO or partnering premium strike range.
1. MHRA Approval.
2. Flaskworks delivery
3. Collaboration announcement. (Perhaps with Keytruda)
4. UCLA Combo results (I anticipate tumor response even though it’s not an anticipated direct endpoint in the current combo trial)
5. FDA/EMA marketing applications
The FDA’s main role is to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. However, the FDA's approval processes and regulations can indirectly influence drug prices.
Drug prices are primarily determined by market dynamics, including competition, production costs, and negotiations between manufacturers, insurers, and healthcare providers. In some cases, government policies and programs may also affect pricing.
Or not.
I think it’s fair to say that on June 29, 3024, LP made it sound like up to that day, HEM preparation was at best in its initial phase.
Or not.
Good DD. I’m not certain your comment on it is on the money, but it’s a reasonable question.
I don’t think it’s negligent lazy, masochistic or unintelligent/mistaken timing, therefore I assume there are other reasons, and other than CDF, or some other interim funding program, I am admittedly hard pressed to know why she waited.
Eden seems a possibility, but the reasoning there would not be obvious or direct. It might have to do with the very pragmatic reasoning that actual commercial launch should avoid a stuttered cadence, and therefore anything prior be treated like a slightly compassionate increased pace. I’m skeptical on that front.
Awaiting maturation of the original OS endpoint might be part of this.
A long shot reason might be the awaiting combination trial results, in order to strengthen obvious inherent societal/economic value of the platform.
At the ASM, it’s as if LP wanted to emphasize and not dodge their seemingly delayed HEM preparation. This leads me back to more wiggle room in the CDF or some other interim funding.
However, the minute funding is provided is the moment manufacturing demand skyrockets. Obviously there must be some tether of time between artisan and EDEN. In the end, that might be the true logistical “sweet spot” that MHRA and NWBO keep in their sights, regardless if it’s not normally a regulatory consideration.
EDEN is a sea change, a massive one, and like the internet, electric cars or military drones, the introduction must be thought out even though the technology’s optimization is plastic and nearly endless.
Go easy on yourself. You don’t take up that much space.
Thanks Adam.
I was saying that you can’t say there is no chance a BP is interested or not simply because NWBO does not have a new combo deal right now.
There could be a perfectly good reason. Like we are days/weeks away from an approval decision, and perhaps a BP would not want to get out their wallet yet.
It’s ridiculous for you to say there is no BP interest simply because there is no combo deal now. It is concrete thinking. They could be interested, they might not be based on your one criteria.
How could I possibly know what payout terms would be? I did not contradict myself at all.
Answer this. Would you make a combo deal with a company just before it was known whether or not their product was approved. I’d say, no, you would not.
This was my first question in the thread.
There are enough facts for me to currently bet (against you) my posting privileges that I believe a combo deal involving NWBO (or whatever entity it is at that point) will be announced by March. There are not enough facts for me to bet my posting privileges what level the drug/biotech company will be, what financial tradeoff will be, or when it will start.
You are scared to take my bet, and want to add contingencies.
No bet.
No. You are still adding contingencies, and you were not right in the first place.
This is the bet I will take, I believe there will be a combo deal announced between NWBO and another company before March 2025. (Hopefully much much sooner).
Take it or leave the opposite side of my bet.
Nope, you added contingencies. BP show interest all the time by working through third parties. I once bought shares in a company making an antibiotic, it was bought for cheap by a small bio, I left with little profit, then that second small bio was bought for a much higher percentage and was gulped down by a large BP (Pfizer) just a couple months later. Large BP work in mysterious ways, and demonstrate their “interests” methodically.
You are exposing yourself. Here is what you said before I joined the thread.
Too many contingencies. It sounds like you don’t accept my bet because you also believe a new combo trial deal will be announced, which sorta makes your previous bravado logic below fall on its face.
LC, You are changing the parameters of the other bet. You are adding contingencies. I bet a combo deal will be announced before March (hopefully much much sooner). If you can’t handle that bet, then no bet.
No LC, again you are adding contingencies to your bet. Try reading my last post again. I needed to slightly edit it.
Just accept my original bet under your original profile LC. I bet maa approval before January 1, 2024. You bet no approval by then. Loser stops posting.
No, I used the term “commercial version”, as I explained, as the commercial version of Eden, but not yet certified. You just argue to argue. Try listening.
If you started with the manual version for a combo trial, you’d be redundant and possibly setting up more verification transitions in the future. Saying, oh gee, those were the first half with artisan, but those were the second half with EDEN. You try to eliminate those types of distractions in trials.
Regardless, you’d want to know DCVax-l was already approved before paying for a new combination deal.
Which you can’t deny. You’d want approval or you’d be wasting your money. At this point.