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Actually, I don’t think other BP figured it out enough to devote the right decade old trials. So if I’m somewhat right, one or two BP seemed pretty dang good at throwing off other BP. Think of all the major admitted fails lately and over the past few years by some BP trying to skirt around the edges.
There’s a reason we are still here.
Even Ex and LC have admitted the science for DCVax is strong, they just beat it up on the periphery.
I don’t want to argue about who’s right and who’s wrong on the reasons for manufacturing expansions at Merck and Amgen.
However, what does “make sense,” although hard for retail like me, is that a BP like Merck would publicly disassociate itself from a future acquisition until progress was cemented to a point where launch was becoming imminent.
There are two primary reasons this might happen.
1. Throwing competition off the track in order to leave them years behind their pivot.
2. Keep the intended acquisition from positive attention for the same reason — to not attract other would be BP into the dendritic cellular vaccine business.
(I will say this, the size and specificity (vaccines) of the BP manufacturing expansion combined with constant talk of tech transfer does not rule dstock’s hypothesis out.)
Actually, he did. He just got tired of putting the year down as well.
I feel like I was right about the list below.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173533762&txt2find=Right%20wrong
Which is consistent with the outsized results in the small DCVax-l + Poly-Iclc trial. The results for each subgroup are excellent, and note the grade iii results. I think this plus what Dr. Bosch and UCLA are discovering in terms of immune response correlation is just as responsible for the industry and regulator sea change as is the phase iii trial and the DC + CI + poly-iclc trial.
flipper44
Re: Dr Bala post# 631506
Monday, 09/18/2023 6:43:02 AM
In that small trial, the DCVax-l + Poly-ICLC arm showed:
100% unmethylated GBM (idh wildtype) patients lived over two years. (n = 4)
100% methylated GBM (idh wildtype) patient lived over four years. (n = 1)
100% Grade III brain tumor patients are still alive. (Between six and ten years). (n = 4)
https://www.researchsquare.com/article/rs-3287211/v1
Yes, the trial did not power itself for survival, but the results in that arm are nonetheless stunning.
Maybe, but long timers here see PPS sometimes lift above 1.00 rather quickly, and
while there is debate regarding what Linda meant by the MAA “cementing,” and what she meant by that allowing combination trials to “proceed” that would be more advantageous to shareholders, one has to wonder if your (some day) monetary return to NWBO might be belated to your disadvantage.
I also fixed/edited a date in my post you are responding to. Whew.😅
So the way I see this as a layman, is that, as Hoffman pointed out, NWBO could finally use the name Murcidencel by November 29, 2023, and, as I reason, that makes the MAA (marketing application) submitted on December 20, 2023, internationally identifiable for collaborative purposes — regardless of whether or not Orbis is being applied.
Moreover, as ChatGPT discusses, resultant publication of that name (which Hoffman points out will occur sometime around January 28, 2024) will allow international interaction to take place without the confusion some naysayers attempted to germinate related to DCVax-l’s standardized unique name — Murcidencel.
ChatGPT reinforcing your recent dialogue with Bard.
The United States Adopted Names (USAN) publication for a new therapy is important for future biologic approval purposes because it provides a standardized and unique name for the drug. Having a distinct and universally accepted name helps avoid confusion in communication among healthcare professionals, researchers, regulatory agencies, and the public.
For biologic drugs, which are often complex and derived from living sources, a clear and standardized naming system becomes crucial. It facilitates accurate identification, prescribing, and monitoring of the drug. This consistency is particularly important during the regulatory review process, as it aids in evaluating the drug's safety and efficacy.
In summary, USAN publication ensures a standardized nomenclature, contributing to clarity, safety, and effective communication surrounding the new therapy, which is vital for regulatory approval and subsequent use in the medical field.
Not yet, but there’s a pony in there some day.
https://searchusan.ama-assn.org/finder/usan/search/*/relevant/1/
Keyword: Murcidencel
Actually, I’d think there might be more reasonable questions asked of management by longs and answered by management if bashers weren’t creating a two party system. Probably be more accountability by management as well. Instead, for about a decade NWBO justified the silent treatment because they did not want to spend all their resources defending themselves from AF and echo chamber. Current status is, one is either labeled a pumper or a basher.
Well, at this point, if DI is still giving the same instant validation on December 20/21 schtick that Senti conveyed a few weeks ago, then there were likely no hiccups with the submission, because we are beyond 30 days, and if NWBO would have needed to resubmit, then Dave could no longer be saying there was immediate validation back on December 20/21.
Just sayin.
I think ex is correct about short interest reporting and dissemination dates? Check again tomorrow after 4pm est. Meantime, here are the rules.
https://www.finra.org/filing-reporting/regulatory-filing-systems/short-interest
Have you contacted FINRA?
Essentially, all Dana Farber occurrences.
If I were a suitor BP, I’d want to be in control of regulatory responses/international collaboration/PIP trial initiations/launch preparation/etc by this point in time. At some juncture, I have to believe one must take the reins in order to pursue objectives more adroitly with all the resources a BP can provide.
Everybody starting to check this site on a daily basis for Murcidencel?
https://searchusan.ama-assn.org/finder/usan/search/*/relevant/1/
Anyway, the very loosey goosey interpretation might be 1/24 (or 1/27) is somehow a point at which USAN publication and Orbis type A might be intertwined for various reasons.
My DD. I dunno,
Anyway, the very loosey goosey interpretation might be 1/24 is somehow a point at which USAN publication and Orbis type A might be intertwined for various reasons.
My DD. I dunno,
And here was some follow up DD by Danish Dude and his buddy Bard.
The Danish Dude
Re: FeMike post# 643444
Friday, 10/27/2023 12:45:57 PM
Well in my infinite wisdom I asked Bard. "He" seems to be "bamming" with me.
What is positive about getting a drug on the Recommended INN list, before it is approved, as DCVax-L now has succeeded with, and with the name Murcidencel?
There are several positive things about getting a drug on the Recommended INN list, before it is approved:
It provides a unique and nonproprietary name for the drug, which can help to improve communication and understanding of the drug in the global medical community.
It encourages national naming authorities to adopt the same name for the drug, which can help to avoid confusion and ensure that the drug is marketed consistently around the world.
It can help to raise awareness of the drug and its potential benefits to patients.
It can help to make the drug more attractive to investors and other stakeholders.
In the case of Murcidencel, a dendritic cell vaccine for glioblastoma, getting on the Recommended INN list before approval is especially positive because it can help to streamline the approval process and get the drug to patients more quickly.
Here are some specific examples of how getting a drug on the Recommended INN list can be beneficial:
It can make it easier for researchers to find and compare data on the drug from different clinical trials.
It can make it easier for patients to find information about the drug and its potential benefits and risks.
It can make it easier for doctors to prescribe the drug and for pharmacists to dispense it.
It can help to reduce the cost of the drug by making it easier for manufacturers to produce and market it.
Overall, getting a drug on the Recommended INN list is a positive development for all stakeholders involved in the development and commercialization of the drug, including patients, researchers, doctors, pharmacists, and manufacturers.
Here’s some Hoffman DD on INN:
Publication of USAN approval typically would be 60 days after 11/29/20/3.
flipper44
Member Level
Re: None
Sunday, 11/12/2023 12:42:10 PM
From Twitter:
hoffmann6383
@hoffmann6383
I assume $NWBO plans to market their product in the US. This requires a USAN [1]. A USAN requires a successful INN review [2]. Following a successful INN review, a USAN adoption occurs the last Wednesday of each month [2]. This means November 29th in $NWBO's case. $NWBO may use (the name) Murcidencel immediately on 11-29 and publication of the USAN approval typically happens 60 days later at the following link:
https://searchusan.ama-assn.org/finder/usan/search/*/relevant/1/
^^ at least that is my novice understanding after reading through the AMA (American Medical Association) website.
() added by me.
More likely related?
This happened on October 26, 2023:
Murcidencil published on the WHO recommended INN
#Murcidencel is now published on the WHO Recommended INN (rINN). #DCVax-L $NWBOhttps://t.co/U4z7BlxtNC pic.twitter.com/zR9A7mpJ71
— Henry (@HenryMuney) October 27, 2023
Probably unrelated, but on 10/25/2023
Interesting timing - Bank of America is closing their Stock Loan Hedge account, effective tomorrow ⚠️ pic.twitter.com/3sqIbxZ7gN
— M.B. (@741trey) October 24, 2023
Agreed, that’s been in the back of my head. Of course there are three timing types of filings with Orbis, we are buzzing around the earliest possible one right now.
Oh, and Orbis recently announced Japan is joining Orbis.
Project Orbis lead Angelo de Claro announced that Japan’s regulatory agency PMDA plans to join Project Orbis. #FriendsAM23
— FDA Oncology (@FDAOncology) November 14, 2023
I’ve been burned more than once. It seems more like AI is currently a tool that one has to teach more than one is taught. I’m certain that will change for the better, if AI is/remains sincere, good hearted and continues to tweak its algorithms and understandings. Aka: Good faith learning.
My latest thought is he’s simply hoping for type A filing under Orbis by January 19th, and guessing it would be filed the 18th for safety, then thinking NWBO, if it filed then, would hold news four business days, which would be January 24. Just a wild ass guess.
That, or he thinks wash out period is for all intents and purposes, done by then.
That, or he thinks any day beyond the 24th is past any possible validation issue notification date. A safety point if you will.
If you go through all his posts on this, it represents 1/24/24, but he got tired of adding the extra /24.😅
Anyway, I’ll be celebrating 1/28/24, and I have no idea why.
I guess we’ll be past “1/24” soon. Breezewood, any thoughts before your day?
Or is it 1/27/24 as your last post below indicates?
BreezeWoodAcres
RE: None
01/12/2024 11:07 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
01/12/2024 12:47 AM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
01/09/2024 09:23 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
01/08/2024 06:43 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
01/06/2024 09:15 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
01/03/2024 03:42 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
01/02/2024 11:46 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: jdheart101 Post # 658093
12/21/2023 11:13 PM
Post
# of 666154
.89c
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
12/19/2023 03:36 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
12/18/2023 03:19 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
12/01/2023 06:46 PM
Post
# of 666154
1/24/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
11/22/2023 11:18 AM
Post
# of 666154
Dump hasn’t really started yet
1/24/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
11/05/2023 08:19 PM
Post
# of 666154
1/24
Posted on: NorthWest Biotherapeutics Inc
BreezeWoodAcres
RE: None
10/26/2023 09:47 PM
Post
# of 666154
1/27/24
19 data points at 36 months versus one, and you go with one. Lol. Your (feigned) self-denial is blatant.
Doc, you seem bound and determined to get shares cheaper than they are now. Just sayin.
This has already been discussed, but here are some of my previous thoughts.
I just want to make one more point on the Elios tlpo versus tlpodc phase ii disease free melanoma trial and show you how they are working like Novocure does. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10401209/
Look at the link/figure below. Now realize that based upon this, they’re currently saying, well since tlpo and tlpodc are essentially equal, we should do a phase iii on tlpo because we can’t really afford to keep trialing tlpodc.
But wait a minute, look at cases at risk at thirty and 36 months.🤨 By 36 months, which is what they go by in their trial “survival section,” only one, that’s right, one data point was used to get their survival number for tlpo.😬 But look, they matured the tlpodc group and let 19 cases be at risk for the 36 month analysis.
You see what they did there? They didn’t bother to build a DC manufacturing base like NWBO, so apparently they said fck it, let’s just get one good 36 month data point and call it a day, so that we don’t have to build up an industry. (They also only had six tlpo data points at 30 months)
(Note: remember the Elios (Orbus Therapeutic’s parent) trial was for melanoma)
https://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=10401209_jitc-2023-006665f02.
Yes, we know you’re down on MHRA, particularly when they approved high impact therapies CRSPR and Covid-19 vaccine first. Followed by your “Big Three.”
Just an update. MHRA is trying to gather more info to help answer my questions related to a “swift approval process” announced by Jeremy Hunt over nine months ago.
Thank you Attila.
Thank you Chiugray.