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One or two months here and there doesn’t hurt when we are sitting on a 10 bagger, LOL! MAA submission/acceptance PR whenever it comes in Q3 or Q4 will be likely a dud at this point outside a big pharma partnership news! Shorts will find something to create fear and doubt such as relatively small market size in the UK to begin with and then the time consuming and tedious reimbursement battle (capping total costs, qualification criteria), lack of hiring activity, and so on.
LOL, I hope the management is not thinking along the lines of what you presented here. That would reflect very badly on their past decisions and how passive and helpless they are currently.
I also get it - never their fault and there’s always a big perception changing event around the corner….since the last 3 years! ;)
Hedge fund army won’t stop just like the social media army unleashed by LP, LG, et al . However, NWBO management has not been able to convince the street that the stock is undervalued. I wonder if the problem lies in the communication strategy or execution or both?
Again, no one is questioning the ph 3 or the new combo data. They are great, but where are the applications based on the phase 3 data? 32 months not enough, it seems!
It will go back down to 60 cents or just below before the end of this week! The increasing frequency of such silly narratives (by the social media army) show desperation and that nothing significant is coming anytime soon.
$3M payment, estate planning, Moonshot…what’s the next carrot they dangle - ASCO presentation? ;)
This is what I have been saying all along. Nothing will move the stock for good except big pharma sales partnership. Not even approvals. Shorts know this management will take many many years to ramp up sales on their own and they will slam it down quickly at any spike!
They can’t even get to regulatory applications for GBM with ph 3 data alone. Forget about tissue agnostic. All deflection tactics used by social media army to avoid questioning around delays with regulatory filings. The narrative has shifted towards ph 2 combo data. No approvals in 2023. And the stock gets slammed again as we head into Q3!
You still trust LP and the crew despite all the BS they have thrown over the years!
Shorts will continue to slam the stock if there is no partnership with big pharma on the commercial side post approval. The shorts know this management will take years to build any meaningful revenue stream on their own while they dilute the shareholders at under a dollar to pay debt and fund expansion. And Direct bites dust for a few more years!
Doesn’t work that way in this field even though it’s a relatively small community. I have been there and doing that for 20 years working with neurologists around the world.
There is a ton of effort on the marketing/awareness campaigns, ongoing market access, sales/ business development to establish new relationships at not only big academic medical universities that were involved in the trial but other centers, operations & finance team to handle the sheer volume, and so on.
The street will still not trust them to deliver on ramping up sales. Where’s the hiring? Only a big pharma partnership on sales/distribution alongside regulatory approval(s) brings the credibility.
Same as you where we both see the share price at 60 cents and how the narrative is shifting towards combo data rather than accountability on regulatory applications!!! The last 30 months was all about blaming others (journal reviewers, authors, Advent manufacturing auditors) for not being in a position to apply for RA. Now 31 months post data lock and 2 months since commercial manufacturing approvals, the blame passes to consultants. Who knows they will bring up another prerequisite in 2023!
We will see when that happens. The narrative has certainly shifted towards combo data though so I don’t expect them to deliver anytime soon.
I don’t think we will see share price stick over $1 consistently in 2023 (except maybe a spike for a few days on UK approval news, if that happens) unless a big pharma partner comes on board. The street does not trust this management to deliver. With the help of their social media army they have been taking retail for a ride for so many years.
As I said, they have strategically positioned around ph 2 combo data and kept retail in the dark. It’s likely they received advice from their consultants and who knows regulatory authorities too asking them to wait for submission until ph 2 data matures. And if this is the case, It wouldn’t be surprising if retail sue this management for lack of disclosure.
The narrative is shifting and nothing is coming anytime soon!
Fully agree. When they start giving excuses like million pages and so on, that’s a sign of bad management. That’s their job and that’s what they get paid to deliver and not complain.
Doesn’t matter. There will always be excuses from folks that shield them. First journal and authors were responsible for delays in TLD, then MHRA for delays in commercial manufacturing certifications (not meeting prerequisite for regulatory submission), and now their contractors for the delay in regulatory submissions. It’s never their fault and everything seems to be outside their control!
As I said, they have been intentionally dragging their feet because of the combo trial data. Regulatory applications don’t take over 2 years to complete even if you are team of a handful of (inexperienced) people!
Just think about it:
1) Why did they wait until early 2022 to apply for PIP when the the data was locked in Oct 2020?
2) Why not use CRL or other CDMO as the manufacturing partner in UK? This way, they didn’t have to wait until Advent commercial manufacturing certification to come online. They plan to use CRL in the US anyway.
These steps all seems pre planned to buy themselves time for the combo data to mature and line other steps around that.
As I said last month, May and June will be nothing burger. Excuses will start pouring in again.
I continue to believe they will be no application submission until phase 2 combo trial has matured to a point where they feel comfortable asking regulators to take a peek. Who knows when that is - Q3/Q4 2023 or Q1 2024? Until then delay + deflection tactics will continue. Blame it on contractors or another prerequisite! And continue building hype around $3M financing!
DI & LG are BS artists. They have been on the 1 yard line for over 30 months now. June will come and go and then there will be summer vacation excuses!
Agreed! And hopefully the partnership(s) will cover both GBM sales/licensing as well as new combo trials. That will be the best case scenario for shareholders at this time.
“Naked shorting and manipulation stops”
- unlikely to go away with this management at the helm because they know they can expect fumbles and mediocrity! A rich 15 year history of this with down rounds and erosion of shareholder equity.
Also, it doesn’t help shareholders of the last 2 years if the share prices drops to 25/30 cents and then jumps one day to a dollar! No one thought 50-60 cents was likely when we were trading well over a dollar for most part of 2021 and 2022. And a further drop in SP is still likely if shorts attack again on the next fumble (no big pharma partner to drive sales upon MAA).
A big pharma partner can indeed change things and bring credibility, but it’s all speculation at this point. I am fairly certain $3M prepayment is not related to a big pharma. It’s just normal financing from one of their loyal supporters.
Class III medical devices are just as time consuming and tedious. Not sure if Optune got approved as Class II or III. And by the way, CAR-T therapy approvals have happened in less than 2 years as well.
The management has not been proactive and it’s basically their lack of experience and ineptitude!
“.70 that night and $3 in the morning open”
That unfortunately won’t happen here given the number of outstanding shares and that continues to grow generously with every passing week(s).
LOl, just like his $70-80M specials revenue projection for 2022! I can’t believe a medical doctor would make such claims on a regular basis.
It all depends on whether we have big pharma partner or not. We will hopefully have a spike in anticipation of MHRA approvals or at approval but it will be short lived without a credible big pharma partner.
Let’s see who those big chunk of C shares go to and at what valuation. That will kind of set the floor for future valuations.
Let’s see when we get U.K. acceptance news! I can’t imagine an application taking 31 months to prepare regardless of how small and inexperienced team you have. They should have applied within a week or two of commercial manufacturing certification. So there is some mystery to it.
Sure, the combo trial data is great and will be a game changer, but like you, I do not believe this $3M is connected to Merck or any publicly traded big pharma for that matter. The fact that social media army is trying to spin it as something big (and connected to partnership) sort of indicates desperation and that nothing of this sort is coming any time soon, IMHO.
In fact, my theory is that NWBO has been delaying the applications intentionally to let the combo data mature. And they will apply when they feel it’s appropriate for regulatory agencies to take a peek at.
Again, I have never questioned the data and the approvals but the timing is suspect! Ultimately, we will get approvals particularly with the backing of combo data and all the KOLs on our side!
Agreed. If a big pharma partner does not come on board from a sales/marketing/distribution point of view around UK approvals then we will get pummeled too….because the shorts know that this group will not be able to scale the commercial part quickly because of the ongoing funding challenges and debt servicing, which will result in not having the resources they need to build the right team quickly as well as the infrastructure…. therefore the revenues will continue to disappoint in the next year or two post approval….so there will be plenty of opportunity to jump back in post approvals if a big pharma does not come on board right away…
This is definitely not a BP. Do you think the board of a BP would approve a prepayment without a contract in place? And importantly will their legal team risk getting such info out prematurely in public domain by another company even if there is no name attached to it? They could have simply delayed prepayment by a couple of days even if a contract was in place. And it’s always the BP that would open the floodgates to the PRs as well as control the narrative and not the small company! ;)
Shows a bit of desperation by NWBO team and likely pressure from existing big investors!
Anyway, the real test will be if there is meaningful buying support (significant increase in volume) in the coming weeks. Shorts and spoofers are not stopping investors from buying as many shares as they want. For now, these folks are not buying it! ;)
LOL! And LG is honest to top if off! Watch his Big Booze performance from over 30 months ago.
Good for you! Hope you get support from existing big investors too soon!
Not really. The volume would be through the roof if there was a leak. Or at the very least, you would start seeing $5M-$10M average daily volume or more. None of the big loyal shareholders are buying. Easy double or triple from here in weeks/months, right? Are the shorts or spoofers preventing them from buying more?
The shorts are here to stay and manipulate, but you can continue to blame them. Doesn’t help retail! What we need to see is significant uptick in buying for a few weeks as well as follow up with swift, meaningful progress around UK and FDA applications. Announce UK and/or BLA acceptance. Not just talk for months, but no real action. We have all heard something big is coming many times and then quarters go by!
I agree with most of what you said, but I can almost guarantee it’s not a publicly traded big pharma. Big pharma’s legal will never allow such disclosures even if names are not given at this time. And I am sure LP wouldn’t do anything to jeopardize such arrangement by prematurely hinting to it’s shareholders!
I agree with you! Such news (if involving another big public company) ought to be protected and premature public disclosures must be avoided at all cost. In my mind, this shows desperation from the company. A sign nothing big is coming anytime soon but they are trying really hard to excite the fan base through their social media army! ;)
And how’s project orbis and worldwide approvals + reimbursements coming along? Which bucket does that fall into?
Good deal. Just watch out that a month or two don’t turn into a quarter or two similar to how months turned to years for the TLD wait?
LOL, $175M in 2024. They won’t even hit half of that in 2025, if they remain independent.
They currently do not have the bandwidth to even execute on $20M order intake on an annual basis. And I am only talking about operations and finance side of things. Not even considering quality assurance/regulatory compliance, business development, sales/marketing, etc. Revenues at such scale just don’t drop out of thin air because you have a safe and effective product for a deadly disease. You still need to build a strong team that can execute on these various business functions.
As the April timeline got moved to May and then to June, it will shift again come June to July. His favorite excuse is everything takes longer with NWBO! ;)
Agreed. Neither the street nor the friends or existing investors trust anything big is coming soon. No buying support!
I don’t know what you consider fast and what annual revenue numbers you consider significant post reimbursement approvals.
“Perhaps it is the cost and no insurance coverage.”
Of course, I have been saying this for over 2 years now. I have been living and breathing this world for 20 years! Even approvals alone will not result in wider adoption due to costs. Reimbursements are critical. There will be a ton of challenges on the reimbursement front as well. It won’t be an easy battle! Qualification criteria, cost limit, and other negotiations won’t be easy.
Plus adoption even after approvals and reimbursements will not be as quick as everyone expects here. That’s just the nature of clinical therapy world. This is already quite challenging for a big established player with a ton of resources. So NWBO will not be able to do justice on their own for sure. It will take years if they remain independent.