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In this case, the target is a protein called uPAR, found on the surface of senescent cells. By targeting uPAR, these CAR T-cells can effectively locate and eliminate senescent cells.
You went down a deep dark hole. Dude, she’s been talking about the already previously conceived combo trials, her intent to proceed with them after the maa is cemented, and in multiple 10qs thereafter stated they’ve been in active discussions — going over a year now.
Some people say, you’ve got to get the price per share up before any buyout offers, but you say “hold my beer, I’ll do you one better, they can’t even enter combo deals til they get their PPS up.”
Bullshit.
It’s the same combos. I can’t fix your inability to comprehend the last time they were possibly going to proceed they announced it, but now, when they proceed with these combos upon cementing the maa, you somehow think not only will they not announce it, but they’ll somehow keep it from clinicaltrials.gov as well.
Read my post again. The entire thing.
She said:
….as soon as we've got the application for approval cemented, we're very eager to proceed with these combos.
Some years ago, some of you may remember, we had hoped to embark upon combo trials years ago, and we actually have reached conceptual agreement with several other parties, and we announced this to do -- to proceed with combo trials.
Unfortunately, from a resource standpoint just couldn't do it from a resource standpoint, and we had to just stay focused on getting our lead program to the finish line, right? But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest than its shareholders.
We have actually -- we actually walked away from a combo trial that we could have proceeded with before. The terms were quite unfavorable with us supposed to supply everything and receive very little. So we're not going to do that. So anyway, that's our perspective on combo trials
My two cents. Linda was basically alerting us that whomever they’ve been in active discussions with, is awaiting the cement to cure on the maa in order to employ whatever terms they have had over a year (now) to work on.
I thought, and so did multiple AI, that cement meant acceptance/validation, but it’s starting to look like Doc is right that it might mean the first 80 days or nearby conclusion of CHM meeting.
There is always a possibility, it is moving more swiftly* (or slowly).
The MHRA is still trying to get back to me on whether or not they’re implementing/developing a faster approval process for high-impact therapies. Previously introduced as a priority in March 2023.
“I have spoken.” — Kuiil
“…. as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest and its shareholders.” — Linda Powers
Fair point. No question we were told the size of the maa increased just before the time of submission. If I recall, NWBO overcame a challenge in submitting about the same time. Combine all that with ATL’s DD, and you may have a Brer rabbit hiding in the weeds, no reason to raise expectations, but if it pans out, all the better to surprise one with.
Thermo posted on otlk board a couple days ago. I’m just glad everyone’s still ticking.
Q-u-a-l-i-t-y post.
I wouldn’t normally engage this, but it’s a good question in a bad wrapper. First you should probably start with why is Keytruda better than Opdivo at most things? Answer: Could be trial design, could be molecular structure. However, what we do know is even something as simple imitating PD1 is not clear cut, but Merck seems to have a knack for doing it right. Right?
Linda literally asked for “help” in 2018. We were sent Dr. Duffy from Merck.
Our SAP was finely tuned.
Our trial completion date was extended.
Our combo application was on a trial sponsored by Merck.
The DC Poly-ICLC trial we initially sponsored was extended.
Dr. Liau joined our SAB.
UCLA researchers kept confirming their Autologous DC is DCVax-l.
Merck has a nasty patent cliff in 2028.
Merck also makes Temodar.
To be continued.
Who, NWBO or Mirati? I think I know where you are going with this.
I just want to get this therapy to patients.
Just sharing the end of Mirati’s story.
Mirati is now a
Bristol Myers Squibb company
Select Accept for Information about Mirati.
To learn more about Bristol Myers Squibb Click Here.
https://www.mirati.com/
He (via NWBO) has a fcking patent. He’s five years ahead of everyone else. The patent goes out to about 2036.
Others can’t use any of NWBO’s L safety or efficacy data from their decade old trials. The major trial Merck is running with UCLA was shared with NWBO so that NWBO could pursue the patent application.
Ex opined
“They do not wait around when they see something they want. And now 5 years later..
Contract and biologic protection from biosimilars.
You’re right, that would be an alternate universe, because here, UCLA knows how hard it was for Dr. Bosch to patent (out to 2036) and perfect the latest optimized version of Direct. Also, several international patents.
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.