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And LG lied again. All the waitlist BS with the specials program!
Hoffman’s and Iwasdiver’s $20M per quarter estimate from 2022, LOL!
Thermo,
Three questions and you don’t have to answer.
1) Will you be disappointed if the shares sold in the combo trial to the partner is under a dollar, if and when that happens?
2) Will you consider supporting Bigger with his activist shareholder stance, particularly if there is no UK submission/acceptance PR this year? Bigger is talking about potentially becoming an activist shareholder post MAA submission. He doesn’t seem to have enough confidence in the management in terms of unlocking shareholder value and rightly so.
3) Can you tell us roughly the net reduction in the number of shares you own now vs June 2020 assuming you sold a few in the rally over the last 3 years? For example, I own 50-60% less shares in total than I had in June 2020. Don’t need to complicate things.
Block that poster and other Hoffman aliases. Don’t respond and let him/her study what an activist shareholder means! ;)
Thermo thought Q2 (April then May then June), LG said UK approval imminent almost 3 years ago on the same show, NICE did the same a few years ago, DI has been saying they are working very very very hard and on the 1 yard line for a couple of years.....
Bigger is considering an activist role at MAA submission (I am assuming if the management disappoint again!).
Not saying UK submission/acceptance isn't happening, but it's certainly not happening this quarter or next unless they update their August 10Q to remove all the ambiguity and instead provide a clear guidance there.
Odds are not in your favor!
“Lucky to see an app submitted first half 2024”
It’s reasonable to expect at least UK submission in the first half of 2024. Very likely they would be in a good position to submit to EU as well given all the work they may have done to this point. Germany is much quicker than UK in getting reimbursements worked out and also bigger from a population (addressable market) perspective. No wonder LG blurted out Germany in his performance last month.
Review the last 10Q in terms of the language used as well as timeline of the prerequisites, regulatory preparation for submission, strategic about regulatory submissions, etc and combine that with LG’s performance on Big Booz show last month. This will provide important clues if you keep an open mind.
It’s a strong indication they are waiting on some more things to line up (which may be expected in early 2024) and hence they are utilizing the window to work on multiple modules rather than just focusing on limited modules for UK and submitting this Spring (in April).
As I highlighted couple of months ago, one of these excuses will start trending as we approach end of summer.
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 or ILAP. 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.
You can stick with your logic and I will stick with mine.
I am not suggesting they are doing it unnecessarily. They are slow walking it for a reason and that is to give themselves the best shot at approval. In fact, it’s very likely that they have received some hint from the agency folks too, but obviously they are not going to say it out loud or PR that! ;)
Otherwise I don’t see a reason why they wouldn’t have been in a position to apply as soon as they received MIA in late March. At that point, they would have had 30 months to prepare from the data lock stage. In short, we should have received UK application acceptance PR no later than May.
No point wasting months preparing and reviewing modules for other agencies particularly in the first few months of this year when they must have known that MIA was coming anytime in Feb-March time frame. They should have ensured that UK application was submitted in April. Then they could have continued working on finishing modules for other agencies once UK application was submitted. I mean they are struggling to keep the lights on so why wouldn’t they want to start building trust and excitement around UK acceptance right away.
The only logical conclusion is they are waiting on one of these things to line up, which is expected early next year. So they are utilizing that window to prepare additional modules and are reviewing them at the same time.
You don’t delay an application by 4-6 months or more when you are struggling to keep the lights on and financing at 50-60 cents or thereabouts.
The bigger question is why do they still continue to beg and plead in the parliament? Seems like regulators are looking for a buy in from politicians given the complexity of the trial?
It is being deliberately slow played because of one of two reasons or both:
1) phase 2 combo data.
And/Or
2) UK regulatory body does not have the full buy in of all the constituents given the complexity of the trial but they are optimistic it will come through in early 2024.
Why on earth would NWBO management and consultants waste precious time front loading 27 modules. I would simply focus on the limited UK relevant pieces and get that application accepted, get a big pharma partnership going rather than wasting many months on the documents that are not needed for UK and delaying the UK application… particularly with how long everything has taken and the situation they have been in with the share price languishing at under 50 cents…
Lol, I wouldn’t hold my breath, at least this year!
He has been pumping non stop for many years and he doesn’t care about the share price. His personal target is to increase the number of messages he posts on various online platforms.
Thanks! You didn’t answer around timelines but that’s ok. Bigger spoke about MAA submission rather than approval as a trigger for a potential activist role/position. Given the pace this management operates, UK approval could still be another year from now.
Since you believe that the prerequisites have been met, shouldn’t they communicate clearly to the market that they plan to submit the final UK application in Q4 if not earlier this year. At least update the language around regulatory (UK) prerequisites amongst other things in their 10Q so it’s not ambiguous. Is that too much to expect?
LG is openly bragging about 1.7 million pages and 27 modules on Big Booz show so I don’t get their double standards around people gunning for them and not disclosing things. Thoughts?
As I have said many times, if they keep their 10Q language around regulatory prerequisites and preparation the same as in previous report, expect nothing this year.
What does success look like for you at MAA submission and MHRA approval both in terms of timelines and importantly shareholder return?
And what point do you team up with Michael Bigger to take up an activist role if they continue to disappoint? Or at least support such an initiative. It must be frustrating that this management hasn’t done justice to this investment given the powerful technology platform and the unprecedented KOL support.
These guys are all consistently getting inside info from the management and trading on a regular basis. Thermo puts out statements every now and then, which traps naive retail allowing him to offload some of his position. Rinse and repeat.
Unlike Bigger, Thermo doesn’t seem frustrated with this management in terms of delivering shareholder returns or unlocking value. So the game may continue! However, the real question is what does success look like for Thermo at MAA submission and MHRA approval both in terms of timelines and importantly shareholder return?
Because a 10Q is coming and he doesn’t want investors to freak out. So dangling of another carrot. I am fairly certain there will be no change in language in their upcoming 10Q regarding regulatory submission. It will still be vague!
As I have been saying, there will be no regulatory submission/acceptance PR this year.
I agree with you. Without reimbursements in place, they will never achieve meaningful revenue to break even.
LOL, look who is commenting. You are 100% involved in pumping! You have been pumping since it was well over $1. Give him credit. He has been right a lot more than you have.
Let’s see what your end of August pump brings! ;)
As I said, it’s going to low .40s or .30s as we approach fall. SNO this year could be interesting if KOLs start questioning the (lack of) progress with the regulatory applications. Will LG and LP brag about 2M pages and 30 modules at the meeting?
But you have said similar things when we were trading over a $1. You don’t seem to expect MAA submission/acceptance this quarter and we continue to get manipulated, so why would share price rise this month or next?
Sshh, it’s an investment for the grand kids.
You would be better served talking to DI and LG on your next phone call and asking them to unlock shareholder value ASAP or step aside. One is over 75 anyway!
Unlike pumpers, normal investors don’t like seeing the value of stock they own erode year over year particularly in a market when many stocks have been up over 10000% in the last 10 years.
LG bragging about 1.7 million pages and 27 modules is being silent? LG talking about applying to UK, Canada, and Germany (EU) is again all about the silent strategy? Talking about fulfilling the prerequisites and preparation for submission before the end of the year is OK too?
But you can continue to defend the management and their strategy, which is clearly all over the place and not working.
No regulatory submission/acceptance in 2023, unfortunately!
Your concerns are spot on but not sure you will get a clear response. Well, it’s actually the job of the management to provide clear guidance to the street and not social media army. What the management has said in previous 10Q is that it is their goal to work on the prerequisites and be prepared for submission before the end of the year. Although they say they want to submit as soon as possible after this phase and that they want to be strategic with their applications. Not sure what as soon as possible mean in management’s mind and how would shareholders know if they are running behind on prerequisites and preparation phase?
Why would they let the share price languish and not build investor confidence like most reputed companies do by issuing a clear guidance on their application timeline. Just a simple statement along the lines of we plan to submit our final application via ILAP or Project Orbis program or the conventional route to X agency before the end of the year? The only reasonable explanation is they are not that close and if they disclose these timelines that stretch well into 2024, there would be a massive sell off.
That’s not too bad then. Hopefully you get a mini pump soon before it starts becoming obvious to most that MAA submission/acceptance PR is unlikely this year!
Will you stop posting here if there is no MAA acceptance PR this quarter?
I don’t think it makes sense to ask this to the poster you are communicating with because he has a lot of patience and does not care about the opportunity cost!
Quacks? Defined as, "An ignorant, misinformed, or dishonest practitioner of medicine."
— LG falls into this description perfectly! One only has to go back to summer 2020 Big Booz show for his take on imminent UK approval.
LOL, he and couple of his aliases + colleagues are on ignore list, but every now and then you need to put things in perspective…
But still way short of that $20M per quarter compassionate use revenue you and diver were projecting back in 2022! You don’t seem disappointed.
Agreed. And if you read between the lines, bigger is also hinting towards some sort of wait before MAA submission. If it was coming in short order, I don’t think he would have put it on Twitter.
His tweet also indicates the lack of confidence in this management in terms of delivering shareholder value. He is worried that MAA submission news and the lack of catalyst around it and how it is delivered could disappoint investors again in terms of share price because the management is still unable to bring big investors and big pharma partner. And that he would be willing to take an activist shareholder role at that point.
“is it possible that the company knows that the regulators are in process of changing official documents on how trials, such as theirs, will be judged. Could it be that they've been told to be patient, don't submit until our changes are official.”
Yes, it’s quite likely. And their conservative and ambiguous language around submission is a proof they are waiting on something to line up and don’t expect it this year…. it could be ph 2 combo data or the regulators asking them to hold off until they formally release more guidelines around such cases. This is why I continue to believe there will be no submissions this year. Otherwise, there is no reason to be ambiguous.
You misunderstand the followers. Bulk of folks that support this management are paid pumpers or group that consistently receive inside info to flip their shares at the right time in order to trap new retail. Rinse and repeat!
Why else would anyone continue to support the management when they have consistently seen their investment lose value over a long stretch of 8-10 years or longer? Particularly when many of the investments over that period have skyrocketed 10,000%.
It will go much lower as we move into the fall.
It appears you bought it a little too soon. If you really wanted to get back in it, you should have waited until the fall to take advantage of the sale! ;)
Nothing is coming this year so it’s another lost year. The upcoming August report will reveal disappointing compassionate use revenue too (no more than $2-3M from last quarter).
Agreed. This is where their social media army makes a living though. If the big news was coming very soon, no reason to have them post and defend non stop.
The management loves to keep things vague and do not care about the share price or financing/dilution at such depressed valuation.
This is what you wrote on June 12, post number 600780, where you spoke about submissions.
hoffmann6383 §
Re: Maverick0408 post# 600772
Monday, 06/12/2023 5:04:42 PM
“continue to believe there will be no application submissions this summer and the narrative will shift to SNO in mid November”
I believe the opposite. Submission is happening this summer. Maybe submissions.
It’s not just that poster. Pretty much all the posters that constantly go out of the way to back the management have been encouraging folks to purchase when we were trading over a $1.
Low .40s or .30s coming near you in the fall. Another lost year!