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Rethinking it a second time, it is very possible that when the abstract was published they fully expected to have numbers by the conference but did not. If so, they would likely wait for the next significant conference to publish.
That would be consistent with both the quoted text and lack of known results.
https://www.ctad-alzheimer.com/files/files/CTAD%20ABSTRACT%202023%20oct%2024_compressed.pdf
Search on lp019
Only presents baseline data, but then states:
Conclusion: The impact of IPE on cerebrovascular health in cognitively unimpaired Veterans will be presented at the conference
It is common to have posters that just describe ongoing trials w/o presenting results.
I am not saying I am sure that is the case, but it sounds likely.
Poly-iclc has meaning only in combination with DCVax-L.
You connect all dots to DCVax-L. Oncovir lists 10 P1/2 trials on their main page, and none of those is DCVax-L or ATL-DC.
Oncovir must disclose the information about the efficacy of poly-iclc combined with DCVax-L which involves the confidential information concerning the third party, in this case, it is NWBO
That I agree with.
And I do think anybody who did accept should abide.
Link?
It was in my initial reply to you:
Dec 8 reply to Hoff;s submission summary
Sorry, I will call BS My bet with you was for approval, not submission, in 2023. And the terms were a mea-culpa sig line. Regardless, looking forward to the NCAAF playoffs, Only 24 days to go.
No.
NWBO will need another trial.
And again, when hoff posted that summary 3 weeks ago I replied the same day calling it lying BS.,
Keep supporting hoffman though despite how much he lies.
I do recall one post with everyone listed and the exact terms laid out. I do not recall your disputing those terms at the time when it was all prominently displayed and longer were jumping in to make their bets too
My bet with you was for approval, not submission, in 2023. And the terms were a mea-culpa sig line.
Virtually a certainty there is no approval in 2023. Only real question is if they even submit in 2023.
This tells me approvals are around the corner as last time it was no JA, ever!
There is no reason to assume NWBO will even be submitting a MAA/BLA in months. There is reason to assume it will be a year or more based on statements in their SEC documents about prerequisites.
Saying 2024 for approval is optimistic.
For Q2, clearly can take those Q2 MAA/BLA approvals off the table. Will be skeptical about a submission in that timeframe.
You will certainly not find all of them. As I said repeatedly since Hoff started posting otherwise my bet with hoffman was on approval and the terms were double or nothing on the sig line.
He then quotes hs own post where he unlatterally change the bet.
Crash is just copying Hoffman's lie.
Yep, exactly! Exciting times
Have we seen what happened to MMTLP?
How did I lose the bet that I offered? That the MAA will be approved in 2023?
I guess it is possible it gets approved next week. But I doubt it.
So basically you, and the other 4 replies, can not actually say where I have been wrong. Just that I have been negative on a stick that has gone from $6 to $0.81 while I questioned it.
OK.
Told people that the real money is with dcvax direct. Experimenting with 12 different types of cancers is huge especially with already promising phase 1 data. Now I'm in it to the end good luck you all.
OK Druggie, please tell me where I have been wrong.
I asserted they had an efficacy IA in 2015 We now know that is fact.
I asserted that the IA pointed to the PFS primary endpoint as being being futile. We now know as a fact that the endpoint failed badly.
I assert that the OS 232 vs 99 failed badly. Anybody who can not see that is clueless.
I assert the FDA guidance on ECA reads poorly for the -L submission. I stand by that
I assert the FDA guidance on tissue agnostic does not apply to -L. I stand by that
I asserted that they would not be approved based on this trial. I stand by that.
I never asserted they could not reach data lock, could not submit a MAA.
Come on druggie, argue facts, not BS.,
Ar you going to be like Steve (hoffman) and call me out on a few spelling errors and one quickly correctly post? Come on druggie, prove it.
You also said that the company would not file for approval in 2023. You’re wrong A LOT.
Never said that. Just hoffman lies asserting it and using his own quotes to support it.
You an actually find posts where I said they are likely to flle "soon" if you look.
You said you would leave these boards if NWBO got the MAA out by 2023,
Immediate targets?
I am saying 1 year with no approval. Most longs are arguing 3-6 months for approval.
I’m in for 1rst quarter approval!!!
Approval.
Acceptance will be a mechanical check. In two weeks cannot possibly do anything close to what the actual approval will entail.
I forget what class I first heard of the insignificant many, and the vital few. I would suspect that if we looked at the 1.7 million page filing with the regulators, 1.699 million of those pages, or more could be classed as the insignificant many. I really doubt that over 1000 pages in the filing really belong in the vital few, and if you're reviewing what's being submitted, it's these pages that need to be scrutinized.
Keep an eye on CVM for that exact reason.
The Multikine UK submission is even more of a scam than the NWBO -L submission, but at least CVM owns their mfg facility (and does not sublease it out for $150k/year)
And yet every day your own dendritic cells keep you alive and healthy by immune surveillance, attacking foreign bodies, directing immune response and monitoring progress to the point of signaling an end to the fight. Right, a placebo!; ). Back to 5th grade science class for you. Best wishes.
At the time NWBO did the sale/leasback the majority of the facility was nothing more than shell space. They had fixed up 15K f^2 or so and done nothing with the rest, There is no hint NWBO has spent any real money on developing the rest of the building.
The GMP facility is Advent's. The expansion into phase 1B is Advent's . NWBO has a large shell of warehouse space behind/under it.
Looking forward to updates on Eden, Flipper. They will rollout good news on their terms.
. continued development of the Flaskworks system, including choice of the system version to take forward;
No, it is an NWBO factory, which is depreciated. Advent has a lease for a small port for offices and to provide additional services to the third parties that NWBO is obligated to provide because of the regional financing.
Hotel Suite 1 (including C lab extension) 2,238 ft2
Hotel suite 2 2,012 ft2
Labs (PD and QC). 830 ft2
Corridors 1,420 ft2
Computer room 75 ft2
---------------------------------------------------------------
Sub-Total 6,575 ft2
Unfinished and/or un-equipped interior space:
Hotel Suite 3 2,012 ft2
Hotel Suite 4 2,012 ft2
Nitrogen cryostorage area 2,560 ft2
Plant room + electrical cupboard 1,300 ft2
----------------------------------------------------------------
Sub-Total: 7,884 ft2
Total Interior Space: 14,459 ft2
To date, the Company has developed Phase 1A of the facility, comprising approximately 4,400 square feet of the overall 88,345 square feet.
Good point that G-CSF (Neuprogen) will help on the WBC issue..
I would suspect it is already used though. Have no idea how much you can keep feeding the patient and how that effects the nature of the moncytes.
Flipper, is the leukapheresis more critical to the number of doses than the size of the tumor? If that's the case, what would prevent doing the leukapheresis more than once.
Attacking management and timelines are low hanging fruit in BASHER land
He lives in Chicago?
Come on Stonk, I will gladly bet you or anybody that there is no MAA (or BLA) approval in 2024, Terms of no more posting here.
Yes or no.
Gee hoffman, you make up bet terms and then use your own words as proof. Again, as I have said for almost a yera since your first posted this version of our bet,
I bet double or nothing on the sigline bet that there would not be an approval in 2023
Does continuing to lie about this and posting your own lies in quotes make it true? I guess so for NWBO longs.
Good to see CRL Memphis has EMA / FDA compliance experience !
Positive results from China, where Vascepa has already gotten marketing approval...and from the Brave Alzheimers study in Wisconsin could provide additional help to Denner in his shopping Amarin for a decent share price sale.
We will never discover how the cropping of the study actually came about...but what we can know for sure...is that the fraud, which was critical for the judge's decision in the case, accounted for millions in profits for Hikma and millions in losses for Amarin.
Does a link to the actual source documents exist? (I have only seen secondaries)
And again we see Specials running through Dr A. Maybe that is the bottleneck for the waiting line?
BTW, why does Dr A not disclose that it his clinical basically running the MD side of the Specials program? Do you think they do this for free?
If it was somebody on the "other side" failing to disclose the same the longs would be all over it. Yet, all OK here.
There is a fundamental concept in trials called multiplicity and alpha spend is used to control it.
Say you have a trial. Look at one endpoint and it is not P<..05 so you go to the next, then the next. Eventually one works by pure luck. Alpha spend is how you account for multiple endpoints. In this trial the design was that PFS was the primary. If, and only if, it was stat sig then OS would be evaluated.
NWBO learned that PFS failed in 2015 based on the IA (anybody who does not know this is delusional). And so they then changed to OS. That is a basic formal no-no.
That said, the FDA and others may well accepted OS as defined (233 vs 99). But that also failed (and again, anybody who does not know that is delusional). So they changed again to OS vs external controls. But now the issue gets far worse as it is not just a third shot on goal; but also goes against much of what the FDA says in their guidance on how to use ECAs.
Sawston is a facility and building. You appear not to understand how businesses work at a very basic level.