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8-10 million a month is not going to be happen on compassionate use in 2022, but let’s see when they report Q1 numbers. I doubt it will be higher than $4M in Q1, and more than $6-7M in Q2.
We will find out when they report Q1 numbers. They should start to see some top line revenue trickle in, hopefully between $3-4M in Q1. And it will steadily increase in next few quarters as impact of the new COVID variant minimizes and once TLD+publication news starts spreading in media, medical, and patient community.
I’d be more than happy if your forecast comes through but I have my doubts. Q1 2022 will still be impacted by COVID restrictions. I put in $200k for my model as well, but I don’t expect more than 100-150 patients on compassionate use in 2022. On average 6 per month in Q1, 10 per month in Q2, and 15 per month in Q3+Q4. And if we don’t have TLD+publication by end of Q1, I don’t think we get to 15 per month in Q3.
Correct. Not sure how they will do their reporting.
Also, I am assuming they will get Sawston certification in Jan and TLD+Publication by end of Q1 for those numbers to hold. If we get delayed by another quarter or so, then we will certainly be looking at around $15M or so for 2022.
If regulatory approvals in UK and EU do not happen in 2022 for whatever reason, my prediction for compassionate use top line revenue is around $25M (+/- $5M) for 2022.
If they do not announce TLD+publication by end of Q1 they will not have many supporters left. So not sure it matters in the bigger picture, IMO.
TLD+publication ought to drop well before meaningful revenue from Sawston is PR’d. Greetings from Big Apple!
Agreed. All signs point to buyout in second half of 2022. Another strong indication of buyout would be if there is no new (major) increase in authorized share count in the first half of next year. That will continue to strengthen buyout possibility. The last 2 financings are steps in that direction too.
Well, they can not come up with any more excuses like waiting for Flaskworks certification, etc. TLD + Publication must drop in Q1, 2022. UK certification update will likely happen in Jan.
If publication + TLD is not out in Q1 then I am not sure I can trust them to get regulatory approvals in 2022. That would also be quite bothersome because they continue to damage their reputation. Why blame AF? They are doing it to themselves by setting false expectations.
I also feel LL knows this is coming as soon as they have FDA approval. Senior Merck executives and M&A team must have communicated with her quite a bit about the efficacy, applicability, experience at UCLA and their collaborators, etc. A big part of her career is focused on this and I am sure she wants to ensure this has far reaching impact, which Merck can deliver.
I agree. The results are outstanding. LL, KA, and the KOL SAB wouldn’t let this linger so long if the results were bad or not significant. We have seen LL and KA speak extremely positively about this work as late as May of this year. Their credibility is on the line too.
Nonetheless, the strong patent activity amongst other things continue to point in the direction of an acquisition by Merck in the second half of 2022.
Some of my buddies from Clearpoint Neuro are meeting LL this week! They are super excited at what they can do with targeted drug delivery on immunotherapy side!
Pretty sure Michael bigger has a hand in making this happen given his investments in both NWBO & CLPT
To add to this, why would LL fight this late in the game (with her presentations during the spring at Mt Sinai amongst others) if the data wasn’t impressive? Also, remember the podcast KA did in May!
Plus LL getting inducted in Asian Hall of Fame for her work on brain cancer vaccine last month.
We must remember that UK and EU have accepted new endpoints and approvals in those regions are over 90% certain. That alone gets us to a 2-3 billion market cap minimum. If our (US) clinical trials website gets updated with our new endpoints in Q1, we deserve a market cap of close to 5 billion, IMO.
I believe TLD+publication will to be released in Q1. If it doesn’t then I start to question their intent. Not sure many shareholders will stick around any longer regardless of what they say about Flaskworks and it’s potential.
Either way, if they are not acquired in 2022 I am not sure this management will be able to fulfill the tremendous promise this vaccine offers. Again, I say time is money. With the promise of AI amongst other things, a company like Merck can really take this to another level.
Thermo, thanks! It would be reassuring to a lot of long time believers if you were to chime in with your take on what may be going on behind the scenes, sequence of events/catalysts, and how you see the recent Advent and Flaskworks messaging from DI to Flipper or one of the other board members (don’t remember).
Heading to Florida to catch some warm weather and be amidst the Disney frenzy with the kids but hopefully we can beat the crowd a bit before it gets worse the following week.
Agreed. We will likely have news on Monday or early next week. There is a leak and I expect good news!
I don’t think so, to be honest. It’s not connected to the journal at all. I think they are still waiting on something from FDA. With the publications that came out in Lancet in October and the internal guideline document they are working on fully releasing in the coming weeks, it appears that FDA is on their side…..however, they want NWBO to wait on something until they update the new endpoints on clinical trial website….And NWBO doesn’t want to offend FDA….they’d rather play the waiting game….
Although if this gets dragged further for a couple more months then I start to question this as well. Why would FDA continue to drag their feet so long for such an important game changing therapy with an unmet medical need? Shouldn’t they move as quickly as they can to ultimately pave the way for approval?
With all due respect, I do not subscribe to the theory that journal would prevent them from updating the new end points on clinical trial website.
It would be a shame if they end up keeping Direct to themselves. Don’t trust them to move that quickly & efficiently through trials, which in turn keeps such an important therapy away from patients longer. Plus they are not getting any younger.
On the other hand, Merck would want both as they would not want to run the risk of Direct getting in the hands of one of their competitors in the future.
I think FDA approval will be the trigger for a buyout. UK and EU approvals are pretty much a done deal based on new end point acceptance and their following particularly in the UK. And if FDA approves first then other RAs certainly will follow. If I were a big pharma I’d purchase them as soon as FDA approval. This way, they can fast track everything going forward. Time is money which unfortunately is not in the DNA of NWBO management.
Direct is also packaged into this deal for sure. The age of this management team just doesn’t support running another ph 2/3 trial!
At this juncture, I am not sure why I would worry about AF and FUDsters anymore. The SP is already languishing at .75 and if there is no meaningful update in a month or two we will be sitting at 0.5. How low can it go? They must release TLD+publication as soon as possible. If we were sitting at a couple of billion market cap then it’s a different story….
Agreed. Either this management is working with a buyer behind the scenes or they are quite non-competent, to be honest. There is no middle ground in this case given what we have seen over the last 15 months particularly (coupled with their history over the years!). If there is no publication and TLD in Q1, I am most likely out. If they do release TLD & publication in Q1, I will stick around until end of 2022 with at least 50% of my position until end of 2022 for FDA approval and buyout scenario.
The fact that LL, KA, and the KOLs on their SAB have stuck with them over the years including recent presentations and podcasts by LL and KA during the spring gives me tremendous hope that we have a winner. Why would LL and KA go out of their way to cheer lead our platform? They wouldn’t continue to fight this late in the game otherwise. The data is certainly stellar and they know it, there is no 2 way about it. The slight bit of uncertainty continues to be FDA.
The other question in my mind is will a big pharma purchase NWBO if there is only UK & EU approvals for L and no FDA? If so, at what market cap?
This is what I have been wondering about as well…particularly on the US side….also, does that mean that this third party (Merck) is happy with their UK strategy (going via Advent)?
Its hard to believe that the market is not pricing in UK and EU approvals yet. We ought to be $2-3 purely based on that.
None of NWBO’s top management or board members have left the company in the last couple of years. That is an indication they all strongly believe that the data is stellar and approvals are coming! On the other hand, if you were to believe the shorts that this is a scam (and they will continue to kick the can) then some of these guys would have definitely left at this juncture and not want to be a part of this anymore.
This is how it’s done. The inspectors would let the QA lead and key executives of the company know they are approving them on the last day of their visit. And a formal certificate is issued within a couple of days.
In our case, they obviously must have encountered some non compliances. And until NWBO team addresses those, they won’t certify. Typically, the inspectors will let go a few minor non conformances and do not withhold certification. The site is simply asked to address it before their next inspection but a formal certificate is issued within a coupe of days .
LOL. After a few glasses of wine, who cares NDA or not!?
Meeting old friends from CLPT this weekend at a neurology conference. Hopefully will get a chance to chat about LL (who is now on their advisory board).
I wonder if Regeneron could come in play with Duffy’s move there? There could be a bidding war if the data is phenomenal as we all believe.
Pfizer and J&J have a ton of cash and I wonder if they want to get involved and compete against the likes of Merck (Keytruda) in oncology space in the future.
This pandemic has put a spotlight on vaccine development and ramp up of these manufacturing facilities. So a lot of big pharmas would want to get involved, imo. It will be interesting for sure!
Thanks for sharing! You are absolutely right folks will do whatever it takes when it’s a matter of life and death. I have been working with neurologists, neurosurgeons, and patients with neurological disorders (on the medical device side) for almost 20 years now. So I understand all of this, but my point being any new technology/therapy adoption is often quite slow in the clinical world, particularly when you don’t have the regulatory approvals in place. Not many medical doctors are up to date on the latest publications either, unfortunately….it will take at least a quarter after TLD+publication to get any meaningful traction on the compassionate use….I’d be glad if I am wrong!
Agreed. Pretty sure DI knows LP has been talking to Merck executives. He probably doesn’t know what Merck has offered to acquire NWBO but in all likelihood knows that an offer is on table as long as they meet certain criteria (RA approvals, patents, etc) and LP accepts it. Otherwise I am not sure a person of his experience would stay patient with the apparent lack of action and urgency around the key personnel and strategic growth initiatives.
Speaking from my personal buyout experience 4-5 years ago in terms of how many people in the close circle of the founders and upper management knew what was going on behind the scenes from the early days.
Nice, that's a classic way of deflecting this topic by almost every executive! ;)
At the buyout, the narrative would change to we realized the tremendous value Merck would bring to our technology and patient community after intense discussions with their executive team and KOLs around the world... ;)
Agreed. And if there is none by end of next year then I am selling all of my position because their expectations around impact and growth is very different from mine.
Given the history of this trial and the original endpoints, it's not that simple. FDA would not want to set a bad precedence, so they are extra cautious....plus they are quite bureaucratic to put it across mildly! ;) I am sure a ton of folks have been involved for quite some time to ensure key stakeholders are on board with updating their guidelines and how they evaluate such special cases....
On a positive note, if NWBO trial indeed has had a big influence on this process update and decision making then I am fully convinced our data is going to be game-changing!
"And the conversion is tied to TLD and a private placement, not an uplist - I find that curious to say the least"
This is quite interesting indeed. We will see whether they end up doing a private placement post TLD, and if so, what size. If they don't or it's fairly small in size then it's a clear indication of buyout post RA approvals.
How often do most clinicians (outside a few exceptional ones) review a publication and importantly are open to changing the status quo? These things take time is all I am saying. I’d expect Advent to handle an average of 10-15 patients per month in Q2 under compassionate program. And we will likely be bought out by Merck in Q3/Q4 time frame depending on how quickly we get RA approvals.
I hope you’re right, but I think they will need more than just positive TLD, imo. Top notch peer review publication and presentations by the likes of LL and KA at major conferences will also likely be needed to convince the physician community at large to recommend a therapy that is not yet approved by regulatory agencies. All I am saying is such a demand is not going to be immediate in absence of regulatory approvals and reimbursements in place. Moreover, I am sure Advent team may also have quite a bit of stuff to take care of from a logistics and personnel stand point before they can handle such a surge in volume over the next 6-9 months.
Without the reimbursement in place, I am not sure if they will get that volume of patients in compassionate use (40 odd per month). It will be interesting to see how it evolves and how quickly the health authorities work to get reimbursements in place. They do have strong following and support in the UK, so let’s see…
That’s great! Hope it works out for him and his family!
These statements really caught my attention on his page:
The best possible treatment, in addition to the NHS standard care he has had, is Dendritic Cell Vaccine which is essentially a personalised cancer killing vaccine made from Joel’s own residual tumour tissue. Given that Joel’s treatment to this date has only been palliative this is the most promising way of actually prolonging his life. The treatment is not yet available on the NHS even though it is recommended by renowned oncologists.
Recommended by renowned oncologists!
I agree the money is probably going to be deployed towards the regulatory processes and consultants while the publication is in peer review process.
It is also likely that we may see the clinical trials registry updated with new end points sooner than later before TLD & pub.
UK manufacturing certification news may happen before year end, but given the holidays and everything else I am not so sure about the TLD+ pub.