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Interesting thread between a neurosurgeon at Brown and the cabal this afternoon.
AF and his buddies are going to get screwed!
And as someone who actively teaches and publishes at a major academic center of course I would not want failed Phase III trials approved. GBM is uniformly fatal with SOC. LL has 15+ year survivors now and I have several 10+. This trial did not fail.
— StevenToms11 (@Toms11Steven) May 11, 2022
The most effective campaign will be when LL, UCLA & NWBO are all highlighted in a single piece by media for this breakthrough advancement and the stellar ph 3 data. I think this ought be happen after the publication is released.
Same applies with KA, KCL and NWBO for UK & EU.
Hi Bob, if the publication does not appear this week or next then I am on your side as well! ;) It would be a big blunder and I’d have a really hard time trusting anything they say.
As for Michael Bigger, I’d think people like him would be very careful in terms of safe guarding their credibility as an investor. That’s not to say you can’t be wrong or won’t make mistakes in your investment decisions but I doubt they would continue to bet on a falling knife (or pump & dump). I personally know a bunch of upper management folks at CLPT and have interacted with their CEO on multiple occasions (we were ex-colleagues a few years back!) and I can attest that they are a great group of hard-working, honest and thoughtful executives. So my point is he is backing the right set of folks if I were to take that as a template from my own personal experience & network. I don’t know about the other company you’re mentioning.
Let’s see how they next few days play out!
Top 3 priorities until end of next week:
1) publication
2) update to clinicaltrials website
3) BLA news
Top 2 absolutely critical! Some sort of update on BLA progress would be nice as well.
It seemed like Annals of Oncology pushed their monthly release from May 10 to 12 for whatever reason from what I understand. Did they get caught in that shift/confusion?
If the publication is not out tomorrow or latest by next Thursday, then I’d agree with your concerns as well.
I have decided to buy more today as we are derisked at this point. There may be short term volatility but you can’t time the market! The data is fantastic and they couldn’t have been more clear that SAP was pre-specified with all 4 RAs before the data lock (highlighted in RED again in yesterday’s presentation adding on to what LL confirmed in earlier presentation this year). Importantly they really emphasized the new innovative trial design using ECA. That shows the confidence within the team while respecting the processes within each RAs.
Furthermore, I can’t remember how many times in the presentation yesterday Dr. Paul Mulholland called it a landmark study and landmark results! This is the highest risk-reward ratio in the market right now, imo.
Having said this, I am still a bit puzzled by their strategy to release the results yesterday (especially after LL called sick). Publication ought to be coming soon. Hopefully some sort of BLA news too. They have had 19 months to plan this.
Good luck everyone!
They had an opportunity to pull out when LL got sick and especially if the publication was not going to be released on time. I’d assume that would have been much less painful.
It’s time for them to show us what they did during the last 19 months! :) No breakthrough therapy or fast track designation or any BLA approval to report so far. Makes little sense when the data is this good!
Don’t know if this is utter incompetence or (over)confidence because they have a term sheet in place?
Know couple of folks that might be connected there. Will try to get some intel in the coming days, but hopefully publication comes out sooner! ;)
Great, thanks!
Down over $500k in a day! Have a second Tesla that I am supposed to be taking delivery of in June by cash. We better take off before that! ;)
By the way, anyone know if Rush University (in Chicago) was part of our ph 3 clinical trial?
That’s right! Still feeling under the weather!
I have said this all along that buyout is the most prudent approach.
Haha. And I cancelled my morning meetings calling sick!
Let’s see if they follow up with series of meaningful news/catalysts this week and next! Otherwise, you simply can not trust them with anything they say!
One thing was clear from today’s presentation is that they didn’t shy away from talking about innovative trial design and new endpoints. I’d have thought they might compartmentalize Europe (EU + UK) vs US in terms of reporting given the uncertainty with FDA, but they didn’t. So they are cautiously optimistic that FDA will accept their BLA application with the new endpoints!
I don’t understand the harm in updating clinicaltrials website as soon as the publication is out. That’s one way to build credibility with the retail investors. The shorts have already done the damage!
If the clinicaltrial.org is updated with new endpoints, we jump back to over $2 and a lot more quickly. They have had 19 months to plan for this so it better come together this week!
Bob, I’d relax and give them until the end of the day today. Why would LL risk her reputation going around various institutes over the last year or so (and as recently as last month) talking about DCVAX-L and historical controls? She wouldn’t have signed up for this event for nothing!
Big move is coming later today. Pure manipulation until the presentation. I believe even more with the action we are seeing now and how desperate shorts have been over the last couple of days.
NWBO management has not overreacted and are handling it well….because they are confident in what they have and cascade of events to follow!
I am logged in and listening to the presentation as we speak.
Shorts are shit scared! The fact they have so active we get a huge lift off today (either just before/after the presentation). Publication on Thursday!
Good luck everyone!
She could have given the talk remotely?
“And any kind of sizable capital raise after Tuesday would not be a good sign.”
Mostly agreed from a buyout or partnership perspective. The SP will take a bit of a hit in the short term but it will emerge eventually.
The other sign I’d look for is whether LP, LG and other executives are selling their warrants and if there is substantial increase in outstanding shares. That will be a big tell. If a buyout or major partnership agreement has been in the works contingent on RA, I wouldn’t expect them to take any action because their positions will be worth a lot more in an year or so. We will see how it plays out!
I think we will be fine. We know UK and EU has accepted new end points. FDA does not want to be left behind when the scientific and medical community worldwide clearly sees the benefit of this therapy, especially for an unmet need.
If the warrant holders were selling, we would have seen a big drop in SP. This is likely manipulation by MMs.
I think we should relax and give LP until the end of the week to show us what tricks she may have up her sleeve. If she doesn’t produce by the end of the day Thursday and rather gives all sort of BS like journal embargo, etc then it’s time to get out! I don’t think this is likely though. They have planned this carefully over the last 19 months!
Wow! Next week or two will be really telling!
Agreed, time to pass the baton! Nothing they have done on the hiring (organization) & go-to market strategic level planning point in the direction of a company planning to stay independent.
There you go and they are not getting any younger!
That’s small potatoes when you are working on a $20-30B buyout. Merck must have had all of that info well in advance, so everything is factored in the buyout agreement.
For instance, an acquiring company will also look into the warrants, NDAs that the company signed amongst many other things as part of their due diligence process.
On the other hand, if there is financing news after TLD then don’t expect any buyout until FDA approval (or at least one RA)….we are probably looking at 2023 at the earliest in that case…
Right and she is going to go out there and show the world how desperate she is for a buyout or partnership! ;)
You ask any founder before they are acquired and they would have given you the same spiel!
Was it LP or LG that said if we get an offer we can’t refuse we may consider it or something along those lines a few years back…
If the data is really stellar as we all expect then it could happen any day between now and ASCO. All of the background paperwork is probably done. Merck may not want a bidding war!
I’d assume Merck has probably had access to data for quite some time and also insights into how discussions with RAs are progressing.
As to why LP may want to take this approach over waiting another year or two, I could think of couple of reasons:
i) fast track commercialization with big pharma resources, thereby providing access to this therapy to patients worldwide in a quick fashion.
ii) big pharma backing BLA will lend more credibility and not to mention their experience.
The other prudent approach is buyout after FDA approval (which is more derisked but could come with higher acquisition cost as there could potentially be bidding war!).
Seems like you talk to her on a routine basis! ;)
Right, that’s why Merck and NWBO must have agreed on a rough framework and price last year or even before. These major buyouts take many months of planning (in fact over an year) for the right due diligence by M&A team, executives agreeing on the strategic direction, and appropriate business plan approval by the board and executives. I am sure they crafted a well thought out 5-10 year vision for how NWBO will add value to their organization, justifying the acquisition cost.
I have gone this experience with one of the top medical device companies about 5-6 years ago, so I can attest from my personal experience.
I’d think we touch a high of at least $6-8 on Tue/Wed with the right catalysts. And in case of buyout, Merck acquires at 100-150% premium the following day!
Correct. It’s well coordinated and there may be other big player(s) involved behind the scenes to support/sustain the share price rise on Tue/Wed such that the premium paid the following day is not outrageous (under 150%)! ;)
I’d think we get buyout or major partnership news this coming Wed! Do note that this PR has to be coordinated with the buyer/partner such that PR from both companies go simultaneously. Also, there is high likelihood they will at least have BLA accepted news PR (from one RA) this week and/or update of clinical trials website with new endpoints.
Either way, TLD PR on Tuesday. Publication this week as well. And everything is well coordinated between journal & NYAS!
Great work and thanks for your efforts! You may also want to add Oct 2021 timeline where two major articles were published by folks from UCLA (including Tim Cloughesy), Harvard & FDA officials about ECA & RWE. There was specific reference to GBM and how it makes sense to utilize this approach in such situations in one of those articles. I’d tend to think that’s when NWBO’s FDA BLA application went in the final gear. We have been 7 months post that!
And to top it off Richard Pazdur (director of FDA Oncology program) et al published about ECA & RWE in Annals of Oncology in Jan 2022!
Merck buys NWBO is the PR on Wed morning, LOL!
Another interesting bit is Senior Statistical programmer from Merck is part of the attendee list too. Quite uncommon, and how much more evidence do we need to understand the game that is being played here?
Sometimes way too much!
We went through a similar exercise about 5 years ago, where I took M&A team and key executives to our KOL sites and some conference presentations! Some of it was due diligence during the early phase of our discussions and the some just validation and building excitement after they had already decided to acquire us.
Unreal! I have a feeling we get buyout this month or at ASCO! ;)