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No point arguing. Already on my ignore list so I don’t even see his messages. It’s best to keep it that way. It will also give the poster time to catch up on some reading around activist shareholders!
Given their history it’s likely going to be longer than 6 months. We will check on the progress every 2 months. Some of the folks here are expecting more than one submission this summer. Time for a reality check. ;) End of august will be our first check in! Then end of October and then finally end of the year. We will correlate the share price performance too!
I have stopped following some of that. Although one thing I do try to track is the number of C shares sold/remaining. That offers some perspective around the likelihood of a partnership deal post UK approval. IMHO, I don’t think they have any partner lined up yet but you never know.
“I would think if they were going to submit this year, he would have said we are hoping or planning to submit this year. Most companies announce when they plan to submit, typically upon data readout, they will give a general timeline of submission.“
Agreed. No reason to let the share price languish and continue financing in distress. The reality is they will shout from the rooftop as soon as the UK application is submitted or accepted.
I read it the same way and that’s why I do not believe an application will be submitted this year! They speak about preparation for submission and not submission itself in 2023. And then you combine that with the real world action (no hiring) and it becomes clear that it’s still 6-9 months away from submission at the very least.
Also, no reason for LG to show up on Big Booz show if the submission was close. He is simply trying to reassure shareholders that look we have worked on 1.7 million application pages so far and we are going to be applying to these various agencies. In a way, he is asking shareholders to hang on and nothing wrong with that. But applications are not happening in 2023.
He didn’t say US out loud, which is concerning. Likely it’s just a brain fart as I trust Dr. Toms and others who are optimistic on FDA as well. Although, as you say, it could be another year or more before they apply.
Agreed. There is no rolling review. In the end, it will be a simple UK application when it’s finally submitted. And as always, shareholders will be disappointed as there will be no meaningful appreciation of share price given how long they took to submit the application and unreasonable expectations that were set with rolling review, etc. No wonder Bigger is kind of on the edge with this management and wants to take an activist position, provided they disappoint again. He’s seen enough!
Let’s hope they submit the UK application in Q4 but in all likelihood it will be in the first half of next year based on their public statements and overall posture. Remember no hiring yet on NWBO side.
A few of us predicted it will be a nothingburger and in the end he will have to resort to his favorite excuse and that is everything takes longer with NWBO!
He is embarrassed. Management toyed with him again! I wonder if we would ever consider joining forces with Bigger to establish a bigger activist position when MAA is finally submitted and accepted?
Someone should ask him what happened to his March and then June approval timelines for UK? And then $80M specials revenue forecast for last year?
He is too smart to be outdone by the management over and over again like Thermo.
I wrote about a month or two ago that one of these excuses detailed below will gain traction as we approach late Q3 with no U.K. submission/acceptance news. Eventually, NWBO will disappoint investors again by announcing only MAA submission/acceptance but it would be almost a year after MIA that its impact will be muted and likely result in another sell the news trigger.
1) The focus has shifted to FDA now? UK not number one priority anymore. So need more time to line up CRL and other million BLA pages?
2) Now applying strategically via Project Orbis. All RAs at once. Need extra months.
3) Flaskworks certification given off label demand considerations!
4) Going after tissue agnostic approvals.
5) No MAA acceptance PR. Need to wait until final MHRA approval (in 2024?) for the big reveal.
6) Rolling review already in the works. Approvals can come anytime.
We will be under 40 cents as we approach Q4 with no update on the U.K. 1st company that loves talking about the number of pages in the application! ;)
LG lies again!
Lol, thank you very much. Now get some rest! ;)
Review the below links at your leisure, it might help. ;)
https://www.investopedia.com/terms/s/shareholderactivist.asp
https://en.m.wikipedia.org/wiki/Activist_shareholder
LOL, Bigger talks about becoming an activist shareholder just for fun!
Good for you that you don’t about worry about the share price performance and opportunity cost!
Ohh if you understood then it’s surprising you didn’t want to admit Bigger is frustrated with the performance of the management?
And what’s sad is our share price performance. I don’t know about you but I am worried about that.
Glad you understand understand the concept of an activist shareholder now! ;)
If anyone that’s helping the hedge fund SMA members, it’s the management by taking almost 3 years and not submitting a single regulatory application. You would be better served complaining there. Ohh wait, they don’t listen and run this as a private company!
Bullish on core technology and potential, but not on the management. That’s why you become an activist shareholder to replace management or force corporate changes. And in some cases, threaten to file lawsuit.
I can’t help you if you don’t understand what an activist shareholder is/does. He is obviously bullish about the core underlying technology but not on the management. My stance has been similar - I am a believer in the technology and importantly the KOLs that support and believe in it, but not the management that’s running the show.
You can continue to support the management though! ;)
Partnership ain’t happening, PM. Bigger seems to be worried that management might disappoint shareholders again in this next phase of regulatory submission/approval/commercial launch with no real tactical and aggressive moves to increase shareholder value.
Why can’t LP PR publicly what some of what LG said in simple terms and importantly provide some rough guidance on their regulatory progress? The way they do it is a non professional way of updating the shareholders and letting the social media army do their work.
I think UK submission is many months away. My feeling is 2023 will be another lost year! It wouldn’t be surprising if LG was BSing again and raising unreasonable expectations just like his big Booz appearance in 2020.
He is not the only one. Some medical doctors also are well known to pump on a regular basis with promises of $80M in specials annual revenue last year and then UK approvals this March then June and I wonder what they will say now when LG has confirmed that they are still working on final stages of the application. They claim to know what’s coming and pump as if the news is imminent and earth shattering. Its likely they want retail to purchase their shares so they can get out and then come back in when they receive fresh intel about upcoming catalyst from LG et al. It’s rinse and repeat, I believe. Otherwise no reason to tolerate this crap from the management for the last decade or so. I’d expect a Bigger like stance at some point. No one wants to be sitting on dead money or be in the red for well over a decade when some of the well known stocks are up between 1000% to 10000% or more during that period.
Because it’s part of the j*b description!
Gary,
The bottleneck is likely at Dr. Ashkan site rather than Advent. KCL is the only center doing leukapheresis on specials program. Dr. Ashkan can only take so many GBM patients per month given his other commitments around Parkinson’s, Movement Disorders, etc.
Overall, I agree they will also need to scale up manufacturing at Advent as they get closer to approval and reimbursements in UK to meet demand.
How many patients did they recruit during that period? If that’s their idea of scaling up a business then we don’t deserve even a $500M market cap valuation.
Doesn’t take away the need for training (non trial sites), finance, etc.
Agreed, but they seem to indicate they don’t have a big pharma lined up for GBM commercialization yet. Bigger seems to think we may be in for another disappointment post MAA submission/acceptance so he wants to take up an activist role, if needed. If a big pharma involvement was around the corner post UK approval, there is no need for him to be involved.
“We will not need a marketing team, Sells Dept.
Build it and they will come! (Internet and people, it will spread like a wildfire)”
BS, doesn’t work that way. You’ll forever remain a boutique shop. Who will go out there and convince the non trial sites, train, and help set up the infrastructure?
He provided a lot more details this time, but he did suggest almost 3 years ago that UK approval was imminent. He should not be trusted fully for sure, but he was a bit more measured in his response this time.
One thing is clear though that they don’t have a big pharma partner lined up to sell/market DCVAX-L for GBM indication yet. Therefore their plan is to go alone until they get approached with an offer they can’t refuse. On the other hand, if they already had an offer from a big pharma and they had a general agreement, he wouldn’t be allowed to talk about this topic or in some instance even make public/remote appearance. Additionally, Bigger seems to hint (based on his comments from yesterday) that this management may disappoint again post UK submission/acceptance news so he may want to get involved once MAA is submitted.
All of this combined with the fact that they haven’t started hiring on the commercial front tells me that the MHRA approvals and reimbursements are at least 9-12 months out. If they were really close to MAA submission and acceptance, I would rather wait a few weeks and then come to the show to add more visibility to that milestone.
I’d also add
E - savvy longs
F - frustrated longs
G - mix of E/F
H - warrant holders
Highly likely under 40 cents with no MAA acceptance news in late Q3, early Q4.
GBM is an orphan disease so they will qualify for priority review and that would cut down the decision time to 6 months from acceptance.
PDUFA dates are typically 6 to 8 months from BLA application acceptance not 12.
Rest of your argument just doesn’t make sense, but if I were you I would watch for their US manufacturing update first. They will let us know once CRL agreement has been signed. Then we can start speculating about BLA submission timelines. Until then there will be no BLA filing. And don’t worry you will also hear the management complain how much work it is to put together another million pages yet again (this time for the US application). And this will go on for a year or more, so you will have plenty of time to catch up!
It’s taken them over 30 months and not just 14 months.
Yup, the million page excuse by LP was indeed a warning sign, but so were also the comments made by LP and LG in summer of 2020 where they lied.
Also waiting for Advent to be commercially certified was another warning sign. They could have used an existing CDMO like CRL in UK rather than wasting 30 months for it to be certified.
I don’t know what is taking them so long. But it’s definitely not due to the contractors. Maybe they have been told their chances of approval would go up significantly if they were to include ph 2 combo data in their application packet? This study is expected to be completed in early 2024. Or perhaps they have been advised to provide compelling data on mechanism of action given the depletion of placebo to fully convince the regulatory authorities. And they are still working on this? Those would be my top 2 guesses. Otherwise, no reason for the application to take this long even if you are a small team of less than a dozen folks.
Doesn’t work that way. UK’s MAA has no connection with US FDA’s PDUFA date.
Don’t expect anything this quarter in terms of regulatory applications.
Kite already had a PDUFA date before they were acquired by Gilead and they completed their application rather quickly. No complains about the number of pages, how challenging and time consuming the process is because they don’t have a reference template to follow for such personalized cell therapy platform.
Their management established great credibility and trust with investors and therefore were successful with raising capital at great valuation!
PIP approval PR as well as all the PRs they put out around manufacturing for compassionate use in 2021 were basically an indication of how starved they were of any major milestones.
You proved my point. Always BS excuses, if they were given to you by the management.
The company that got personalized Car-T cell therapy approved for the first time by regulators didn’t complain they didn’t have this or that…or they didn’t complain they were the first ones to get such product filed and therefore no set precedence or reference to work with…..They got approved in normal time frame.
That still doesn’t justify lying behavior!
Also, there is no excuse for not being prepared to submit the application immediately post MIA in April. They would have had 30 months to prepare at that point. This whole narrative of blaming outside contractors and how things are outside their control just shows how inept and inexperienced the team is.
Regulators are not going to review and approve the application until you submit.
They will definitely PR acceptance. Even if they don’t PR a submission that’s OK because it’s only a matter of 2-3 weeks more.
However, I just don’t expect anything in Q3 and likely Q4. And Bigger probably knows or senses this too.
What’s interesting is a sudden change in tune from Bigger. Just a few weeks ago, he posted something along the lines of him letting the management know that 2022 performance was not acceptable but 2023 appears to be heading in a decent direction so far. Did he finally realize that he misread the situation again or was being fed BS by the management?
Just like Thermo, he probably got fed BS by this management and is frustrated with how long this has taken and importantly management being unable to unlock shareholder value.
Also, I wouldn’t be surprised if he has had a chat with LL too given their connection at Clear Point Neuro. Some of the executives at CLPT are friends and former colleagues so I know LL advises in limited capacity for one of their business units and Bigger is invested there too.
At least it’s clear MAA has not been submitted and is likely many months away! ;) He does not seem to have the confidence regarding the MAA timing and/or the next set of catalyst(s) following the application in terms of unlocking shareholder value. This is what some of us have been saying regarding this management team!
It sounds like he does not expect any big pharma partnership either.