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Sure, but these things take a while. And there’s always competing interest from
big pharmas where they are going after similar talent and will offer lot more money for similar positions. This is unfortunately the reality of a small, growing organization where you are competing for limited resources with big boys. Again, I speak from personal experience in a somewhat related space.
Reasonable approach and that’s what I had intended to do on management compensation votes.
LOL, doesn’t work that way in the real world regardless of how good your product is. There will be many competing interests. You need people not only to bring awareness, open up market access, but also on the process and execution front. Otherwise you remain a boutique operation.
And don’t underestimate regulatory challenges even after you’re approved. It’s a never ending battle to remain compliant.
Another thing to note is that buyer wants to PR the acquisition news and control the media blitz. We experienced this first hand.
Not surprising NWBO’s UK based PR company was parted ways with amicably recently. Something big is coming for sure!
Agreed, but don’t underestimate the personnel requirements in other functions to scale quickly and sustainably….as well as new business opportunities and other clinical trials….
We went through an acquisition about 5 years ago from a top 10 medical device company. Our acquisition was fairly modest as compared to the value NWBO would command even for a partnership at this time, but despite that there was quite a bit of legal, regulatory, and accounting stuff that slowed things down. We had FDA and other regulatory approvals from Europe, Japan, China, etc for our products and they were obsessed with double-triple checking these as well as our manufacturing/QA processes.
During the very late stages, we didn’t hear from the acquiring company for a few weeks and we were a bit concerned whether it was going to go through or not. And we had already gotten shareholder approval internally. They were super tight lipped and worried a lot about SEC implications due to some sort of leak or insider trading.
Agreed.
A partnership or joint venture with anyone other than big pharma(s) does not make much sense. They will struggle to get meaningful traction commercially as approvals roll next year even if they get $200-300M injection of cash from a biotech fund. If their intention was to remain independent and do sales/marketing themselves, they would have started hiring a while back. Or they are not thinking big and are content with remaining a boutique shop in 2023.
No partnership deals coming anytime soon. That’s clear.
FDA BLA news could double or triple the stock price overnight. I am afraid almost everything else is a bit baked into the price. Although the floor has been set.
FDA BLA acceptance would be massive! LL seemed super optimistic without saying it out loud yesterday.
I, for one, would like other promising biotechs to join this movement. These crooks would continue manipulating other upcoming biotechs and thereby preventing/delaying important advances that improves patients lives. They ought to be punished!
Kudos to LP and the management for a well planned strategy! It’s also amazing how the top neurosurgery departments around the world are supporting our therapy and excellent data in unison.
Do we get the partnership PR you (we) have been anticipating on Monday? ;)
He is on point and that is what you expect in most well run publicly listed businesses. In fact, their future compensation should be tied to stock performance too.
A lot of folks won’t support management bonus. You are being ridiculous with those excuses.
This is reasonable and I am leaning towards this as well. Their future compensation ought to be tied to stock performance as well and something that should be brought up at ASM.
His business is in real danger of being shut down within a few months of reimbursement approvals in UK. No reason to wear the helmet for 18 odd hours a day when you can get a simple flu like vaccine shot (couple of times a year) with minimal to no side effects and excellent quality of life. And more importantly, ours will be reimbursed while helmet will cost $20-30k per month.
Reeks desperation. I personally didn’t believe in naked short theory, but all of these silly attempts kind of makes me re-think this.
I am speculating this Thursday! Fingers crossed! ;)
Couldn’t agree more. Overall, easier to work with than European regulatory bodies. In the medical device, we have seen this change take effect 5-7 years ago. If you had asked me 10-12 years ago, I’d say go after European medical device certification first and then FDA, but not anymore.
Happy Thanksgiving, BB! Can’t wait to see how the next week or two goes.
By the way, I will be in Bay Area in early Jan again at an investor conference and look forward to celebrating our success with some of you there.
Agreed. I expect partnership(s) or buyout this month or next.
Not sure if this group of management wants to run a full fledged commercial entity either at this age, so it’s all zeroing in that direction.
Why would they hold off on publication for couple of months when it was formally accepted in late August? They have been working on a deal. These things take time but my sense is we see something before LL’s talk in early Dec.
I do not agree with you or ATLinsider on the timing of RAs. I have been saying this for a while. MHRA approvals will be Q1/Q2, 2023. Second in line will very likely be FDA in the second half of 2023 (likely Q4). You can get FDA approval in 6-8 months from BLA and its almost 50% of the overall revenue for most big pharmas. So from a commercial perspective, you ought to go after FDA, particularly now that the guidance document is formally published.
EU takes much longer, closer to 12 months. They are also super back logged, so this could be longer than normal. Speaking from first hand experience in the field.
Either way, MHRA first and FDA second. However, partnership agreement(s) can change how some of this is executed.
Exactly and that too a JAMA Oncology article. The medical community is behind us!
Great job by NWBO management team to rally the neuro oncology community behind them and LL, KA! No easy feet.
Now it better culminate into a major partnership or buyout in the coming weeks.
Nature Reviews Clinical Oncology is bullish and supportive of DCVAX-L ph 3 results. This is massive. It has a very high impact factor - 65. Even higher than Jama Oncology!
We will get approved by all RAs, just a matter of time. Very likely, we won’t be trading as NWBO anymore, but MRK!
In the phase III externally controlled trial of autologous tumour lysate-loaded DC vaccination (DCVax-L) vs SoC for newly diagnosed or recurrent glioblastoma demonstrates promising median OS durations & meaningful increases in the tails of the OS curves: https://t.co/hJwfoQ6H0I
— NatureRevClinOncol (@NatRevClinOncol) November 22, 2022
It seems we have some big news coming tomorrow with the action we saw during the late stages of trading today. Fingers crossed!
I agree. The clinical and research community is behind us. Over 70 of the top neurosurgeons in the world are supporting us and so are patient advocacy groups. No way FDA or any RA ignores this. I speak from personal experience as well.
Importantly OS data speaks for itself! Hopefully we get a major partner soon to accelerate our journey.
Correct. I know quite a few big multi billion medical device companies that get in big trouble due to QA issues (product recalls, etc). Not just about sales/marketing/support, operations, finance, R&D, etc. So many facets to running a thriving yet sustainable multi billion corporation in pharma & medical device space.
Seagen could be a template to how the early partnership may be structured between NWBO & Merck. Hopefully, our end game would be positive with a massive buyout in an year or so (once we get FDA approvals and there is some data on combo trial?).
I agree with your take. Likely a partnership in the next few weeks culminating into a buyout post FDA approval in the second half of 2023.
It ought to be fairly close even if it doesn’t happen next week. At least that’s my bet. And I don’t see any path other than amajor partnership or buyout in 2023. They have done nothing to stay independent in terms of building a commercial team.
The support we enjoy from clinical & scientific community is astounding and no major company would hesitate to acquire/partner with us anymore. It’s coming!
Sure, does look like it. The fact that they withheld publication for almost 3 months tells me something big is coming next week. Likely partnership announcement coming next week!? Fingers crossed.
Released a few hours ago:
This would mean we can expect more fireworks soon!
No. This is not much different than the peer review process at NYAS. If this was going to be sensational, LL would have been allotted more time (close to 30 min and not 10). I attend close to a dozen neurology/neuroscience conferences every year in US and Europe and quite familiar with how these work.
No journal article next week and I think we take another short term hit the following week. The 10 minute abstract presentation is not going to move the needle, unfortunately. We need JA in a top tier journal and hopefully some real guidance/progress on RA applications for sustained action.
Abstract alone is not going to result in any meaningful action. We need JA next week or we take a hit the following week!
Correct, if it’s the same thing that’s been revealed by KA and LL in the previous scientific talks since May 10 this year. I’d think we will get a bear raid if nothing happens between now and Nov 20.
On the other hand, JA in NEJM or one of the top journals could be a different ball game altogether.
No surprises on my end. I didn’t expect much until mid to end of Q1. Commercial manufacturing certification news is baked into the pricing unless it includes Flaskworks into the mix (which I highly doubt).
Let’s see how the market reacts to JA. Hopefully it comes out before the end of the year, but I am not holding my breadth.
I agree. Chess with NWBO management only results in one outcome. Abandonment by NWBO player! ;)
Even if there were some naked shorts - we traded in teens and twenties for multiple years and why wouldn’t they systematically cover during that period? Hundreds of millions of shares exchanged hands during that time.
Why would “naked” shorts keep their positions open for over 5 years when they have had fantastic opportunity to cover for what might be well over 1000% profit when we were trading in teens and twenty cent range for multiple years.
It’s all BS! A narrative that management wants some of their loyal supporters to paint to cover for their poor execution and importantly lack of investor traction over the years to get us what we deserve.
The fact is the management has been diluting us at sub dollar for a number of years.
Agreed, a very impressive list of clinicians supporting NWBO. It better be showtime the next couple of weeks! ;)
DI & LG should work with consultants to update the damn website at the very least to earn their pay check! Just shows the company’s attitude towards things.