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I respectfully appreciate all the work Dstock and others are doing to gain due diligence on vaccine manufacturing by some BP.
While I can’t draw any conclusions, I did make one small observation.
Regarding the Merck/Moderna melanoma vaccine project, mRNA-4157, it is Moderna that is building manufacturing for potential future approval, not Merck.
(In earlier posts I’ve already shared my critique of mRNA cancer vaccines being a convoluted strategy, wherein targets (between 0 to 34 peptides) are chosen by human technology, coded on to a strand of mRNA, injected into the body, hopefully engulfed by dendritic cells, then hopefully effectively expressed by dendritic cells. It’s an expensive process that unfortunately still allows for tumor escape and for unknown reasons, adds an otherwise unnecessary step into what otherwise should be a more natural broad spectrum process.)
I’m not certain I followed everything you said, but one reason I think there are one or more BP deals already penciled in is the restraint on going forward with Direct for this length of time. It’s unconscionable, imo, and I can’t reconcile cost benefit after this long, unless someone else is saying “wait.” That goes for other L indications as well. I used to see it (aka: just get L for GBM through first), but the time burn on these technologies is absolutely insane. Patient suffering seems an acceptable casualty, which most of us cannot understand. It hurts to think about the time and lives that flowed under the bridge on our generation’s watch.
Somehow I knew that was coming.
Doesn’t make sense. I wish NWBO would explain the money flow. If Les wasn’t exaggerating on big biz about the number of patients processed, why is NWBO not recording revenue? Is it against regs for NWBO to make money under the specials program? Is it against regs for Toucan to profit? If Toucan is profiting, does this disincentivize NWBO cross management Toucan from doing things like NWBO announcing validation, or from getting approval sooner? Does Toucan get more out of this than they would if things were commercial? I assume everything is legal, but the money flow does not seem transparent. Does it? I’d just like to know. BTW, I’m fine if it’s just going to maintain Advent’s readiness and maintenance costs, to avoid us from diluting more, but I’d be bummed if Toucan is making out like bandits here. I assume they are not, but again, I don’t know how it works.
TTsr
I wonder if you’d mind looking over this answer from Bard and tell me if it jives with your experiences?
Big pharma companies do indeed engage in marketing small biotech drugs without owning the IP in various scenarios. It's actually becoming increasingly common as big pharma seeks to fill their pipelines and address unmet medical needs. Here are some reasons and benefits for both parties:
Reasons big pharma might market small biotech drugs:
Innovation gap: Large pharmaceutical companies often face an "innovation gap" where their internal R&D pipelines struggle to produce high-value, first-in-class drugs. Partnering with smaller biotechs brings access to fresh innovation and promising drug candidates.
Reduced risk and cost: Developing drugs is expensive and risky. By licensing promising therapies from smaller companies, big pharma can avoid the high upfront costs of R&D while sharing the risk of failure.
Filling niche markets: Many small biotechs focus on orphan diseases or rare conditions with unmet medical needs. Big pharma companies with established commercial infrastructure can efficiently reach these niche markets, benefiting both patients and companies.
Boosting reputation: Partnering with innovative startups can enhance big pharma's image as a forward-thinking company committed to cutting-edge research and improving patient lives.
Benefits for both parties:
Biotech companies: Gaining access to big pharma's resources, expertise, and global reach allows them to quickly bring their drugs to market and reach a wider patient population. This can generate substantial revenue and accelerate development of future pipelines.
Big pharma companies: Gain access to promising drugs without the full investment of internal R&D, potentially shortening the time to market and securing potential blockbusters. This can fill their pipelines and address unmet medical needs, boosting both revenue and reputation.
Types of arrangements:
Licensing agreements: Similar to BP's example, big pharma companies license marketing and distribution rights for specific drugs from the biotech company.
Acquisition: In some cases, big pharma companies might acquire smaller biotechs outright to gain full control of their pipelines and expertise.
Co-development agreements: Both companies collaborate on the development and commercialization of a drug, sharing costs and risks as well as profits.
Examples:
Roche and Genentech: This successful partnership has brought numerous innovative drugs to market, including Avastin for cancer and Rituxan for autoimmune diseases.
Novartis and Alnylam Pharmaceuticals: Novartis licensed Onpattro, a drug developed by Alnylam for a rare genetic disease, demonstrating big pharma's interest in niche markets.
Overall, the trend of big pharma partnering with small biotechs for drug development and commercialization is mutually beneficial and plays a key role in bringing innovative treatments to patients faster.
“Tobacco.” If you could comprehend what was right in front of you, but you can’t, so there is that.
Imagine a very very old man talking from his front porch, sitting in his rocking chair, staring off in the distance. Takes his tobacco pipe out to speak.
Some says validation, others says 80 days from submission, still others says around CHM. Still others say maybe sooner than 80 days and downright swiftly, whilst the yellow bellied contemptuous folk say later than all these.
You have no clue regarding what terms she negotiated. None.
But that’s the whole point. Commercial Launches are expensive, you use some of the prior combo trial capital, instead of diluting, you handle launch, raise PPS and reduce dilution, and generally make approval look like what it really can be, an initial entry into a market by a fiscally strong company.
So, a large BP can know when an maa that was submitted is cemented. NDA in hand.
A large BP (or several) knows how to calculate future value.
A good faith combo trial with upfront and milestone payments can raise PPS and screw the market makers and hedge funds. It’s real money. Its external professional validation.
An approval without that first is just asking the hedge funds to beat up on us again. If it doesn’t pop on approval, then there is no leverage. You shot your whole wad.
I understand you all believe we are in the buy shares range on the chart right now, but Jeez.
I hope they are sticking with LP’s plan to proceed with combo trials upon cementing of the maa submission.
Hope all is well. Waiting for Doc’s response to my question others are so eager to answer.
FEMike said:
You're not going to convince me of something by using vague quotes from the lying, spineless Linda Powers.
I’m simply following the CEO’s words on “cement”, If they have changed their position, it’s not anywhere to be found.
Last time you went into such a horrific tirade about LP, the MIA came a couple hours after your liar assertions.
I’m asking Doc.
Doc, I’m lost, where is the first .55 bottom of your double bottom? What specific date?
The main thread was about combo trials after maa cemented. I gave an example, that even in buyouts some companies are actually willing to pay real value instead of being tethered to beaten down price per share of their target.
And of course I can’t tell you the terms of what LP has been in active negotiatings with companies privy to trial data for over a year. I’m an outsider.
You call LP a spineless liar.
I don’t make that assertion. I think she said what she meant and she meant what she said. Proceed with combination deals after maa is cemented.
I wasn’t talking about NWBO getting bought out in this thread, I was talking about combo trials beginning once the maa is “cemented.”
It is not a PPS calculation, it is a future valuation calculation. However, you’d like to see every little company get squished into market hit after market hit until they give in.
LP’s strategy is better. Not yours.
Are you FeMike?
Anyway, read post 666966.
Fine, my memory focused on the 10.50 buyout price, but my point remains, some companies aren’t squishing little startups and are willing to pay what a company is worth (in that case a 5x premium), and that is not always equivalent to anything near its beaten down stock price.
You can do the math if DCVax-l gets approved as SOC in Gliomas and then all solid tumors. That’s called future valuation. It’s not hard to do, and no one looks at current PPS to arrive at that.
What smart companies do is realize their strengths and weaknesses. NWBO’s weakness is future gauntlet after gauntlet risk with a small contractor based company, BP’s weakness is it keeps failing and making people sick with toxic potions.
NWBO’s strength is it has a powerful platform that initially still includes the need for the oncology surgical community (non threatening) it is safer than anything out there, it has observable immune system method of action with biological markers, and it clearly can be enhanced with combinations. BP’s strength is the ability to acquire (sometimes)great therapies and get them to the global public much faster than small companies can, and absorb the risk whether they partner, buyout or merge the smaller company as a wholly owned subsidiary.
This is such old recycled trash.
Anyway,
Companies work out terms of joint patents ahead of time. They are not enemies as you well know, and NWBO is obviously the orchestrator of unreleased terms.
You know which patent I’m talking about. Not the narrow one.
NWBO is likely the least concerned that the combination patent only covers gliomas.
NWBO intends to use DCVax-l for all solid tumors. It will likely very soon have biologic exclusivity for ten years from approval. Something I believe Keytruda loses in September of this year, and loses its patent in 2028.
The point is, that combo patent and combo trial go hand in hand in terms of rights.
For ici, LC and you to suggest NWBO is out of the picture because they did not run the trials but only prosecuted the joint patent (with obvious internal assignments and agreements) is just dimwitted.
Regeneron bought Checkmate pharmaceuticals for a 10x premium.
No, it’s just a stupid question. Whoever LP is dealing with can calculate future value for a company with a cemented maa. It’s not up to LP to pump up the price while NWBO is attacked, it’s up to NWBO to reach meaningful milestones in order to achieve more favorable combo terms, which, may in turn, cause a PPS rise.
Just because KG owns billions in Merck and Merck could get NWBO cheap if only KG puts Citadel’s thumb on the market maker scale (you wish), doesn’t mean a combo trial can’t be entered on the basis of real discernible progress.
Not only that, but even for buyouts, companies such as Regeneron know this ‘crush the little startups’ occurs, so they just bypass the games and buy out a company for a ten multiple premium.
We all know you want LP left with nowhere to go. If you had it your way, no one at NWBO could use the restroom if PPS doesn’t rise first.
Okay. Are you following? NWBO (assignee) has a joint patent application with UCLA (assignee) and Revimmune (assignee) and NIH/NCI (assignee, assigned by NWBO)
The combination trial with DCVax-l, Poly-ICLC and Keytruda has the following sponsors.
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Merck Sharp & Dohme LLC
Phase One Foundation
Oncovir, Inc.
The combination patent application is temporarily abandoned, but, according to your buddy Exwannabe, whom I believe in this case, NWBO filed a timely continuation.
Do you know one of the reasons these assignments occur? Because of prior agreements between the parties. Do you know who is pursuing the patent? NWBO. Do you know why the other parties allow NWBO to pursue the patent? Because of prior agreements.
When the combination trial began, it was an outcome of joint effort resulting in a joint patent application.
LP is an expert in intellectual property. You, are not.
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..