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LMAO.
Yes, I stand by my claim they were 100% certain to miss the 11/28/2022 deadline that newman posted by over a year. And they did miss that, and by over a year.,
I went on assert they were 95% to miss this years Nov deadline, which they also missed.
Try harder,
Never made such a bet.
Why do you support Hoffman;s lies? Afraid to debate on actual reality?
My bad.
I think acceptance is reasonably expected next week but maybe one week after that due to holidays.
For me the most important Ra after UK is U.S. However I gotta feeling Canada will follow UK shortly.
Apologies for this question.I have seen the answer posted on ihub in '23. "from the time of an maa filing, what is the mean tine to acceptance? " Also, range, please.
So realizing you would have lost a bet on approval in 2023 (which is what I offered) you unilaterally change it submission.
And then use your tag line change as proof.
Seriously Hoffman, who is the target market for your lies? The tiny fraction of current NWBO longs? LOL
Now here you go changing your time line again. You said no approval for at least one year from submission!; ). Best wishes.
Again One more time. Once they get ok with submittal in less than two weeks (so the approval clock will start) they can start applying for other RAs not simultaneously but some period between like a month or two. Look the other company flipper posted it did back in last June (UK) and then apply for FDA in July.
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Apr. 3, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the rolling Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for the investigational treatment exagamglogene autotemcel (exa-cel) for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)
In Europe, the Marketing Authorization Applications (MAAs) for exa-cel were submitted in December 2022 and validated by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2023.
I tend to be over optimistic. I think the approval from all RAs could come in three months. I assume everyone would agree Project Orbis is included.
Might want to double check your facts there flipper.
On phone now, but the MHRA submission was in Dec 2022. It was accepted in Jan 2023. The FDA submission was later
Absolutely,.
Do to the multiparty conspiracy one cannot assume NWBO shares purchased through retail brokers are valid. Best to get physical paper certs.
The cost and overhead of this is not bad.
. Transfer your certs to a ComputerShare (CS) Direct Registration System (DRS) account, CS is the registraw for NWBO so the official list of who owns what.
. Pay CS to print the paper certs for you,.
When t is time to sell, you can check to see if any retail broker actually accepts these. If so the process involves getting your notarized signature on the paper and sending by registered mail to the broker.
Some have reported this is difficult for OTC stocks so you might want to convert back to a CS DRS account. CS does not buy/sell, so from there you have to find a broker who will accept a transfer from CS. If so, complete that transfer and be done.,
All this is critical as NWBO shares in a broker must be assumed to basically counterfeit.
-------
OK, the above is per dstock's post. IMO, the basis is complete nonsense. Shares of NWBO in any major retail broker account are solid. If not in a margin accoutn using amrgin they are not even being lent out.
One has to wonder why "longs" are presenting this crap thesis that NWBO shares at retail brokers are flawed.
Gee, thanks for letting me know that trial exists and uses Oncovir;s Poly-ICLC.
Now, can you please explain how that supports the absurd statements made by dstock?
Per dstock (and now you, dd and others):
Poly-iclc has meaning only in combination with DCVax-L.
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
Why?
The points are solid.
. NWBO has not mentioned the UCLA ATl-DC trials for years. Why not?
. The clinical trial registry does not list DCvax-L as a name it is known by even though copyrighted names are used in other cases of this nature
. The process for the ATL-DC used by UCLA (details below) is very different from that of DCVax-:L..
.... ATL-DC has every dose for a patient individually manufactured and used fresh. -L makes all in a single batch and freezes.
... Initial maturation time of ATL-DC is several days longer than DCvax-L
... Activation time is several hours longer. for ATL-DC than DCVax-L
.... Additional leukos may be performed as neeed to get more, fresh monocytes.,
. Several 3rd party reports have Prins saying it is NWBO's product.,
As opposed to this we have LL saying they are basically the same. What does "basically the same" mean either legally ownership wise or to the RAs.
Manufacturing differences per the Prins paper
6.5.3 Co-Culture of Dendritic Cells with Tumor Lysate
One day prior to each immunization, aliquots of the autologous dendritic cells will be thawed. A cell count will be obtained, viability assessed, purity evaluated, and an aliquot removed for sterility testing. The DC will then be centrifuged in preparation for loading with autologous tumor lysate.
...
DC pellet will be resuspended in 2 ml of tumor lysate in RPMI medium (noserum) and incubated for eighteen (18) to twenty-four (24) hours at 37 ºC and 5%CO2.
6.5.1 Preparation of Autologous Dendritic Cells (DC)
The flasks will be placed in the incubator for 7 to 10 days of culture.
The first CTLA-4 inhibitor, ipilimumab, was approved by the FDA in 2011. The first PD-1 inhibitors, pembrolizumab and nivolumab, were approved in 2014
The foundational research leading to the blockbuster PD1 drugs that we have today preceded those first approvals by decades beginning in the 1980s and 1990s. I think it’s important to appreciate that PD1 blockade technology didn’t come to fruition overnight.
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.