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I think there is a tendency to project how they will deal with revimmune’s patent interest in the dc + ci patent.
IMO, LP would have had that worked out in some agreement of understanding with the three or four main parties back when she had the patent app filed in 2015.
I simply can’t worry about these things. I assume it’s just a very good thing Europe, in addition to a few countries outside Europe, already granted the combination patent.
Thank you.
CNBC returns to giving NWBO pps in realtime. Chart not working very well though.
Thank you.
Once an original Eden prototype is selected, what is harder to mass produce, the mechanical features, the disposable parts or the programmed microchips?
With manufacturing (as opposed to product), normally, if MHRA approved Eden first, any FDA reciprocal recognition would be smoother, imo.
Typo: GMP
Who here thinks the commercial (gmo) grade units have been sent to Sawston by now?
Google Gemini
Actually, because the final motion deadline is not until June 14, (which defendant’s will surely wait for), it makes sense for Laura Posner to wait until May 31 to file her response.
May 1, 2024: MTD + Support Docs (25 pages)
May 31, 2024: NWBO’s opposition (25 pages)
June 14, 2024: Defendant's reply (10 pages)
Next questions. Will T+1 catch/trap more naked shorts?
Will there be more FTDs after a stock has a massively positive event that carries over for at least two days of trading?
I should have said, how does t+1 effect the good faith free rider rule.
It appears, though I could be wrong,
After May 28, 2024, the scenario below would apparently no longer violate the good faith free rider prohibition, because they waited until Day 2 (aka T+1)?
What is a Good Faith Violation?
A good faith violation is the purchase of a security with unsettled funds, and subsequent sale of that security before the proceeds funding that purchase have settled.
Example:
Day 1 Sell 100 XYZ @ 20
Day 1 Buy 100 ABC @ 10
Day 2 Sell 100 ABC @ 15
The purchase of ABC is made using unsettled proceeds generated by the sale of XYZ, which will not settle until Day 3. Because the ABC is sold prior to settlement of the XYZ proceeds used to make that purchase, the sale results in a Good Faith Violation.
How does this impact avoiding the “free rider” prohibition. Does it mean when you sell a stock, and buy a stock immediately thereafter, that you can then sell that newly purchased stock the next day?
No it doesn’t divide retail. NWBO will take the best deal to move these technologies to treat cancer whether it’s through a franchise model, being the subject of a wholly owned subsidiary buyout or some other structure. You seem to fear a buyout offer. If it’s not enough, the board will recommend not voting for it, but just an offer itself would inevitably increase the pps and allow better capitalization to…. move this technology forward to help fight cancer. IMO.
DL, I disagree. LP even stated if there was an offer they couldn’t refuse, they’d take it.
If so, you’d think at least one BP would want to
own the whole kit and kaboodle instead of playing nice with all the other “operators.”
If that is correct, I would assume they initially need front money/capital from these (many?) “operators” in order to dedicate enough manufacturing capacity and support network plus a profitable cushion to strengthen NWBO as more than simply a going concern.
If so, it is these arrangements I assume they are speaking of that they intend to announce once the MAA process is “cemented.”
“….or buyout….” Learningcurve
My stars, a pig just flew past my window, and the weatherman reported hell froze over.
What meeting? There is no time, no location and no invitation. That makes it difficult to answer your question.
That could solve a lot of reimbursement timing questions.
BTW, my guess is the reimbursement will be the same whether it’s made via artisan or closed system automated. Only the profit margin would change for NWBO/Flaskworks, and perhaps Advent, imo.
Do you recall the name of the company?
You should know better.
They contend NWBO are timing Eden approval with maa approval. I’m saying, imo, Eden is:
1. “Several” months out from early February having gmp grade authorized machine made, according to NWBO.
2. Several additional months out from getting “validation” of those machines conducted.
3. Additional weeks to months from getting engineering runs conducted and that data turned into MHRA.
3. Additional weeks to Months from getting a determination from the MHRA.
In no way does that fit a 150 day timeline from the beginning of this year for maa approval. Senti, who often bemoans NWBO time scales, should know better.
If what hyperopia and senti say is true, then it would mean delay of the maa timeline, not the other way around.
I do believe NWBO is trying to get Eden approved, but to relate it to maa timing is a senti hyperopia creation, not a NWBO announcement.
What good does speculating do? Raise hopes that approval will be a bigger event than just approval? Yeah, that’s exactly what it does.
They should know better.
I have read it multiple times.
Now you read this.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174241069
And this
https://investorshub.advfn.com/boards/replies.aspx?msg=174241069
Hope not, but they sure are completely full of it on this one.
….And obviously, the selected Eden prototype was not and will not have yet been manufactured gmp authorized, validated nor test run before the 80 to 150 days from submission. (None of these will have occurred.)
Makes it kind of hard to provide Eden manufacturing info upon maa submission — “when applying.”
It is just insane what Senti and Hyperopia (aka: nwbo trying to line up Eden with DCVax-l approval) are suggesting.
They ask you to believe:
1. At the same time NWBO knew it had not even selected the prototype for Eden,
2. They submitted a marketing approval (150 day) request for DCVax-l
3. That they only wanted to take 80 days for review prior to either an RFI or MHRA determination period.
4. But really, they planned on day 45, to spring a request to change the approval request to be based upon Eden manufacturing instead of artisan,
5. When Eden had “several” more months before gmp compliant units could be manufactured and “qualified” plus several more months before it could be validated and engineering runs could finally be submitted to regulators for yet more months of MHRA determination.
6. It would be absolutely inane to request a 150 day DCVax-l marketing approval process to be based on a manufacturing process you hadn’t even selected a prototype for, let alone only selecting which prototype at day 45 of the 80 day review period. Imo.
Instead, NWBO has been meticulously planning to start commercialization with the artisan manufacturing process that was ready and expanded to meet over 90 patients a month upon commercial approval of DCVax-l. After which, at some point when Eden passed muster, they could transition to Eden to meet a much larger market.
Duh.
Linda Powers, March 2023:
You’re either confused or trying to buy cheap shares.
They have artisan manufacturing right now!
To move to Eden will require “several” months of getting gmp compliant units manufactured, then several more months (combined) for qualification, validation plus engineering runs to send data to evaluators for an additional two to three months of evaluation/determination.
At best, you are naive to think this could be done within three months after DCVax-l approval.
Duh. That’s why we have an artisan manufacturing facility process to ramp up to 1200 or more batches the first year following approval. It’s ready!
That’s why we’ve been working with NICE for a decade to align reimbursement.
That’s partly why we already had a specials program for over a decade. IMO.
This 150 to 210 day maa process is built for commercial artisan initially.
Actually, wtf does this have to do with maa submittal?
Here’s what I think Senti, you are full of it. Of course they are trying to get Eden gmp units manufactured, qualified, validated, and the engineering runs done asap, but to suggest they would slow down approval to wait “time” for Eden is ridiculous.
They have artisan right now. They can move to Eden sometime after approval when Eden gmp grade commercial units are manufactured, qualified, validated and the engineering runs are also completed.
Instead you wrote:
This part I have and still agree is possible, except for the Flaskworks process occurring within that time frame. Reimbursement might require some time (two to three months) after approval. Imo.
I don’t think you understand that cannot be consistent with a 150 day approval process. It’s not just engineering runs, they must validate the product. If this was a bait and switch, I’d probably move on, because it would be one too many timeline distortions. Hopefully, you are wrong.
They have capacity right now to treat up to 1200 patients a year or more in the UK with the artisan method. That is time to begin commercially ramping the UK. Time to do validation and test runs and then transition to Eden after commercialization.
Suggesting they are completely scrapping that 1200 patients a year commercial artisan method plan with which they originally applied for approval would mean more than 150 days.
Glad you aren’t always right.
Senti, are you of the opinion Eden will be approved “upon” DCVax-l approval or are you simply suggesting Eden will start engineering run testing upon DCVax-l approval?
FeMike at one time thought:
April/May optimistic.
June/July realistic.
August pessimistic.
FWIW