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I didn’t say I agreed with him, I was just bashing you, because you bash other people. If you would have initially picked up on what I was stating, it is highly unlikely an 80 day response (which may or may not include an RFI) has even been written yet, or if written, less likely still that it has been digested yet. Very unlikely, but not impossible.
In the meantime, traders trade on this moment when very confidential information is super unlikely to leak, but traders create the impression, through PPS pressure, that a leak has occurred, imo.
FEMike is a trader. In the mornings he occasionally likes to make a big deal over premarket bids and asks on the NWBO otc. That’s a trader’s ploy, but I assume he must have made coin over it afterwards on occasion, or he’d not go back to it.
It’s clear to at least seven other posters and myself.
Your reading comprehension has greatly declined. Get some sleep.
Actually, if January 2 was when MHRA confirmed validation, then 80 days would fall on March 22.
In other words, while I would not be surprised if MHRA got their 80 day evaluation done a couple/few days early, it does seem to overlap with the March CHM meeting dates.
My guess is NWBO is in the exact midst of finding out next steps this week.
The price pressure reminds me of the traders that like to try psychological ploys, such as start taking a stock price downward when currently publicly unknowable major decisions are occurring, in order to give the impression a leak has occurred that it’s not so good. I don’t believe anybody at NWBO or their contractors that read the 80 day review would take any chances on leaking it to anyone, but the impression is trying to be created by traders nonetheless, imo.
? No, it just looks like they needed to resubmit because there was some PDF transmission error.
I don’t know when this first became the most likely scenario, but it appears any new trial that NWBO initiates from here on out, will utilize Eden system type manufacturing. IMO. While announcements for such trials should happen substantially sooner than their initiation, I suspect closed system automated manufacturing (commercial grade) will be the only standardized method for producing DCVax products utilized in trials. JMHO. Time has a funny way of explaining new (likely) realities.
Any possible current planned buyer might get swooped if they continue to dilly dally.
That DCVax-Direct patent (aka partially matured), for treating solid tumors, which expires in June 2036, has now been granted in at least the following countries:
AU2016286112A1
2023-02-16
Granted (Australia)
2021-09-21
US11124768B2
Granted (United States)
JP2021191885A
2021-12-22
Granted (Japan)
IN201847003183
March 18, 2024
Granted (India)
India. DCVax-Direct Patent Grant. For solid Tumors. Goes out to about 2035 or 2036.
$NWBO patent granted on March 18, 2024 - IN201847003183 🇮🇳: "Optimally activated dendritic cells that induce an improved or increased anti-tumor immune response"https://t.co/8Sbs08Ndd5 pic.twitter.com/TuW6Ad6e9P
— Henry (@HenryMuney) March 18, 2024
Correct.
Im unavailable for a few hours, but if nobody responds correctly to you, I’ll try later today.
Many things are changing in the MHRA review process and NICE’s appraisal process and targets.
If this case is needed to be reviewed by CHM March 21 or 22, the initial corporate expectation by NWBO is that it would follow normal RFI course (60 clock off) then 70 days.
I believe they made every effort up front to make review and appraisal devoid of self-inflicted errors, and therefore have created some better case scenarios even though they are not willing to project those.
Radically, this case might go to determination without chm and RFI, or go to chm but avoid RFI before determination. Those are very slim odds, but I think the same type of upfront effort NWBO made to receive a fast deferral decision with PIP in 2022, could be the same type of effort that might see something faster than 150 + 60 running its full course, particularly when MHRA and NICE have done so much to get their own house up to speed.
Probably, and to repeat myself, I think the numbers have already been crunched. Atl has pointed out how relatively economical DCVax-l is, and Senti has opined (post-approval) 250,000 price tag pre-Eden to 150,000 post-Eden. I think that sounds likely.
I’m probably the last person to follow individual GBM cases for any lessons, (because therapeutic efficacy is determined in hundreds of cases) but being that it looks like Owain’s case was written up and provides such a window into MOA, I am hopeful, if Owain carried through with DCVax-l therapy again, this time from the distal recurrent tumor whole lysate with enough bulk to hopefully reduce recurrence, that it gives researchers and regulators another real glimpse why getting as much of the tumor as possible to make lysate is critical, whilst also demonstrating the reasons why DCVax-l is not only capable of causing tumor regression (with very little lysate available), but is also capable thereafter of slowing or stopping a second true recurrence once greater tumor tissue is available to make lysate. I wish the very best for Owain regardless what he decides, and simply point out his case could be a window into why prolonging life is so much more important than simply demonstrating tumor response.
I also think the reservoirs implanted might enable follow-up experimental therapy like DCVax-Direct or some other therapy if a second recurrence happens.
It just seems to me that by now, NWBO and NICE probably have a firm handle on the maximum reasonable wait between (likely) approval using artisan manufacturing, and bringing on board Eden for cost reduction.
Whether that allowable wait might be six months 12 months or perhaps 18 months, one would think that the numbers have been crunched for both artisan and automated.
I do not think it is any coincidence whatsoever that NWBO and NICE resumed the timeline after the MAA was submitted, and when the exact Eden prototype was selected and sent to a commercial manufacturer to mass produce commercial grade units.
Really, think about what you are saying. A VC is what NWBO is forced to turn to, but instead of just accepting somewhat toxic terms, you think LP should just take any other underhanded spoofing dilution and downward price pressure that follows, because anyone who takes a legal financing deserves to be subsequently illegally screwed by MM and VC.
That’s an abusive philosophy.
You were the one who brought up Fife, dopey. Get some rest.
No dopey, that’s you.
Making vague and stupid accusations while Cohen/Milstein/Posner lay out the facts in a real complaint. You think spoofing is just making sausage, part and parcel of financing.
Psst, it’s illegal.
I’m not the lost puppy that said this:
Put your thoughts together dopey.
Spoofing is illegal.
Can spoofing rise to a Federal Crime?
This was the first Google result that came up.
https://www.justice.gov/opa/pr/eight-individuals-charged-deceptive-trading-practices-executed-us-commodities-markets
Exactly. It makes me want to read the 2nd amended complaint front to back when it becomes available.
Are you suggesting warrant holders above and beyond VCs had true-up leverage to sweeten their warrant buys based upon twenty day price depreciation (caused by spoofing) after the initial exchange?
Hoping to see the full second amended complaint. What I’ve seen thus far allows me to understand far more clearly behaviors, transactions and motive far more than I previously did — I think. In an organized historical context.
WTH are you talking about?
Anyway, remember, one of the VCs is Fife. Hello? Chicago? Starts with F ends
With E. Seriously, get some sleep.
What the hell, you ask a question you know your answer to, and you can’t spit out the word Fife.
Your question was there for you to answer.
Are you having trouble answering your own rhetorical questions?
Hint: One of them might start with an F and end with an e.
In other words, this is a smoking gun that shows how another pot of (NWBO’s) gold was obtained by ne’re de wells when some very timely intense spoofing was utilized.
In other words, motive, opportunity, intent, illegal action, unjust reward.
In other words, the vultures/MMs use spoofing at opportune times, because it works for them. What is better proof than that?
Can anybody make more sense than me regarding why ta/hst might be responding per the linked post above? On February 29?
Also see:
Note: 14 weeks without public consultation.
https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-highly-specialised-technologies-guidance/HST-interim-methods-process-guide-may-17.pdf
Umm, it happened when I said it would. Does that mean you owe me free beer as well?
DocLogic has been following product release closer than me, but mulling over the quoted paragraph below, and stay with me on this, makes me think the “substantial progress” they made would stand out much more now, but for the fact it has (likely) just been inspected in recent days/weeks, and if it passes, then a major announcement will be given, but for now, they gave us some idea of what they feel they have accomplished.
In other words, I think these product release streamlining improvement efforts are awaiting regulatory approval, which is likely part and parcel of the maa review. IMO.
Heartening. Thank you.
If/when approved, it has 10 years biologic exclusivity from approval. It will have 10 years orphan designation (exclusivity) as well from approval.
Combination patent goes out to 2035.
DCVax-Direct is protected out to 2035 or 2036.
Flaskworks manufacturing patents are out to as far as 2040.
Hyperactive DC patents, if granted, will likely go out to 2039.
Did Harrington take the same tact?
Great. (Weird. Court listener still has not posted it)