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Exwannabe said:
“Another incredibly stupid theory that points to the core fact that NWBO is only able to sell stock to those who believe in pure nonsense.”
Good effort, but Julia Childs must be turning over on her strawberry cloud.
It’s a stretch to call approval the end of a trial.
You said:
FDA approval only needs to be expected by the end of the trial which is what MHRA approval portends.
Toucan has nine lives.
That song is messed up.
1. It doesn’t take a long time to bake a cake.
2. How the hell could he not know who put the cake out in the rain.
3. And why’d his recipe disappear forever? Did he bake it with the cake, because the cake in the rain didn’t cause a recipe to disappear now did it?
The Prometheus timeline has been discussed previously. I think what Hoffman is skimping on is:
1. August 9, 2023 actually was discussing the second quarter which ended June 30, 2023.
2. The likelihood that NWBO would announce its earliest “active discussions” with other parties is unlikely. In other words, August 2023 is unlikely a starting date of any kind.
3. At the December 2022 ASM, LP stated that they looked forward to proceeding with these combination trials once the MAA was cemented.
4. At least some of the combo trials forecast
By LP we’re conceptually designed with the parties a few years ago.
So while it’s great to cut and paste a rundown of the Prometheus timeline, one might suspect NWBO is simply waiting for some cement to cure.
There is a tendency, sometimes, to slip into the notion that delay in moving forward is bottlenecked by the CI Pharma companies’ stranglehold on the biotech economy. Particularly the PD-1 group. Perhaps that was/is partly true, but obviously coming to an end.
On the other hand, there was Covid, resulting in well known supply chain shortages for companies around the world, and the UK morphing out of its Brexit cocoon. These obviously slowed progress.
Right now, it seems like Advent’s, MHRA’s and the UK’s chance to shine, and, along with alternative interim reimbursement
pathways in the UK, step up for their citizens, whom are not fairing well in GBM treatment under the old system.
Advent is incentivized to use its brief but forthcoming pre-Eden commercial era well, in order to help fellow citizens, help prepare for eventual Eden commercial engineering runs, and ultimately transition much of their production workforce from manual UK production, into automated UK production for UK, Europe and beyond.
It’s hard to imagine more humanitarian and economic motivation for Advent, Flaskworks/NWBO and the UK to get on it and start easing the suffering of fellow citizens, and eventually, patients around the globe similarly situated.
Would any possible buyout suitor want to nip in the bud LP’s plans for combination trials with several parties because would be acquirer would not want to be tethered by such contracts?
If so, wouldn’t this justify paying a supreme premium above the PPS in order to avoid such tethers?
Any idea why Lovance would finance (211 million) before Market had a chance to weigh in on Friday evening’s approval? What are they expecting after the opening bell, and why?
The nature preprint article is poly-iclc with autologous dc.
Different from:
The others you speak of also include CI.
I see your logic now. Thank you.
Recent movement.
1. Combination patent application in Europe to be granted, includes both DCVax-l (lysate pulsed) and/or DCVax-Direct (partial maturation) with checkpoint inhibitors.
2. Over 60 days since MAA was filed.
3. MHRA and FDA looking at further cooperation.
4. Nature Journal article on DC/poly-iclc combination study nearing publication. Primary completion date for study occurred twenty days ago.
5. Active negotiations with other parties for combination trials going on for over a year, awaiting MAA to be “cemented.”
6. Large pharma struggling to adapt to upcoming patent cliffs.
7. Cohen/Milstein/Posner about to file second amended complaint, and with it, formulaic method to arrive at loss causation.
8. Ihub message board drifting toward speculation on possible suitors and valuations regardless of PPS suppression.
Can you expound on that? Regardless, thanks for your response.
So, let’s pretend a buyout occurs. What is the new pharma likely to do with:
1. NWBO’s Legal case against market makers?
2. The derivative case against NWBO?
I think plaintiffs can also file for summary judgment.
Ask a legal eagle if it will be a judge or jury trial, if, on the rare chance it does not resolve before trial.
“What one woman can do….”
It’s Biosect’s link, not mine. Numbnuts.
Ex and I have gone back and forth on this before.
The U.S. patent application that Ex brought up has a continuance filed, not published, utilized that graph shared by Dr. Liau with Dr. Musella. It has since, uncharacteristically disappeared, the document is no longer accessible.
I’ll look.
Edit : ….patent application that you brought up has a continuance filed….
Dr. Liau is one of the inventors and is on NWBO’s SAB. UCLA is an assignee. NWBO is an assignee. You and someone nicer are from whistle higher? Am I right?
We’ve had this discussion. The U.S. patent that you brought up has a continuance filed, not published, utilized that graph shared by Dr. Liau with Dr. Musella. It has since, uncharacteristically disappeared, the document is no longer accessible.
Here’s some more discussion on that from way back when. I’m certain NWBO must have already known this. Their combo patent application was in 2013/2014.
flipper44
Member Level
Re: vator post# 28272
Tuesday, 01/13/2015 8:16:32 PM
Normally, one has to bathe the immune system with checkpoint inhibitors through infusion for them to work.
It is just a hunch on my part, but with direct, if a checkpoint inhibitor is used as an adjuvant, it may be possible to localize the CI application somewhat.
I could see Direct used for its normal immunotherapeutic application, which includes/results in t-cell stimulation and proliferation. Once the t-cell population is built back up, CI's might be injected near the local lymphs used in tandem with DCVax-Direct tumor injections to take the brakes off the local immune response. This might be a way to greatly minimize CI side effects (by avoiding complete systemic infusion) and yet extend the therapeutic aspects of DCVax-Direct/immune system.
In short:
"In another embodiment, the present invention provides for a method for reducing the toxicity of a checkpoint inhibitor or enabling therapeutic effects to be obtained with a lower dose or fewer treatments of a checkpoint inhibitor, the method comprising administering to a subject a therapeutic cancer vaccine or adoptive T cell or NK cell therapy and a checkpoint inhibitor described herein" — NWBO upcoming patent
Thus the potential advantages from using DCVax-L with CIs are:
1. Improving safety profile for CI by combining it with DCVax-L. — flipper44 — April 2015
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) February 19, 2024
This simply cannot be overstated as to how important this is.
With known safety concerns relating to CI's already known:
Patterns of toxicity burden for FDA-approved immune checkpoint inhibitors in the United Stateshttps://t.co/bKk3KuVXbn.…
You “wait” for acceptance, I believe MHRA has already confirmed it.
The judge has only now ordered to adopt the magistrate’s recommendations. You are confused. It is now within the 30 day window for plaintiff to file the second amended complaint. The plaintiff’s attorneys have stated in filings that they are prepared to provide the information the magistrate recommended/requested.
The MAA is currently “held” by MHRA.
In cases like most of the stocks you probably invest in, if an maa is not held after 30 days, that means it was not accepted (validated) and a new maa would have to be filed.
Beyond 30 days from submission, MHRA confirmed the DCVax-l maa was being “held” by MHRA.
Inquirig, you are responding to yourself again. Slow down and try to remember when you are changing handles.
MHRA already confirmed the marketing application was filed by NWBO and is currently held by MHRA.
“Sawston and UCLA” — inquirig quoting itself.
On February 16, 2024, the European patent office announced it intends to grant a combination patent NWBO has been seeking, which should last nearly a decade, and instead of celebrating, you go to an ihub
Board for NWBO, which you are not invested in, and try to trash NWBO’s IP progress.
“Just my opinion” — Inquirig
Your opinion is incorrect.
That’s the guy that rarely uses quotes. He’s peculiar that way. I do not get paid to post. In fact, I pay about $12.00 a month to ihub for my membership.
10K coming up.
The European patent office indicated on February 16, 2024 that it intends to grant NWBO’s patent application combining autologous DCs (partially matured and/or lysate pulsed) with CIs (PD-1 and/or PD-l1)
Again, one must remember that NWBO’s combination patent prosecution utilized data from Merck’s and UCLA’s study. In other words, there was cooperation.