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You don’t want to admit they lied, but they did! Just as LG lied on big booze show over 30 months ago that U.K. approval was imminent.
Agreed. It will be sell the news if there is no meaningful guidance on FDA BLA. I seriously doubt any major investor will back this management. History of fumbles, down round, relegated to OTC over the years and compliance issues, lack of appropriate org structure to thrive commercially in the near to mid term, no FDA timeline, no regulatory and commercial biotech experience, etc.
Of course, they knew that major corrective actions were found during the first inspection and that a second inspection was needed once those issues were addressed internally. For some of us that are familiar with this world know how it works! So your BS ain’t working here! ;)
More embarrassing is the fact that the management has not been to file for RAs 30 month post data lock. Any well run company (big or small) would have filed for FDA BLA within 12 months of data lock. In our case, there is no guidance from this management on when they will file a BLA and we are 30 months out. How embarrassing is that?
Agreed. The last 2 loans they took from the same company was spun in a similar way by loyal supporters.
They are all a bunch of liars. They lied to us at the ASM in late December suggesting they are waiting on MHRA when they knew that a second inspection was needed to address major findings. Nothing new for this management.
They person who consulted with them for a few weeks couple of months ago was specifically brought to help fix those issues.
It sounds like it should be very easy for LP et al to bring the next strategic investor at a minimum of $2-3 share price post MIA then! Or would manipulators and spoofers (or market turbulence) be blamed again?
I agree. Alternatively, there would be a hostile takeover and Merck would put it out in public domain.
Given your network in this field, what’s your forecast for revenue this year? Will we do 20% of the revenue you predicted for last financial year ($80M)? ;)
And at what share price do you think LP will sell the next trench of C shares to the strategic investor that is coming in post MIA? The board will benefit immensely from your insight!
It was a negotiation strategy for better comp!
I hope the two of you don’t have to endure much longer and are certainly not here next year still looking for that elusive exit at your target price! ;)
The more they talk it becomes evident they haven’t made much progress on the various RAs (outside UK), particularly FDA. They don’t want to publicly admit it, but something seems to be holding them up and they are not being transparent with the shareholders. Otherwise no reason to waste so much time to file a BLA in the US, which is 50% of the market. They could have started discussions with CRL long time back to get the manufacturing online for the FDA application. All this talk about FDA being corrupt and they need Flaskworks for approvals is BS!
You can’t have it both ways! They will open their mouth when big warrant holders put pressure on them so they can sell during that pump. Remember LG statement in summer 2020 saying UK approval imminent. What was that?
There is nothing to report. Whenever they do have something, they will shout from the rooftop. To avoid being exposed, they resort to this strategy.
They are simply lazy and don’t care.
On the other hand, Mike Scott and his team from Advent would have done a nice job! But it’s too intricate a project for the semi retired crew at NWBO! ;)
No one is questioning JAMA publication or the data. But they haven’t been able to use that to bring credible investors on board at a higher floor. Instead they have been selling shares at 60 cents to their friends. And that’s a fact!
Not just that they should have applied for PIP soon after the data lock. They did not. Did they not know about this requirement?
Also, they should have used CRL or other CDMO for their UK regulatory application while continuing to work on developing Flaskworks at Advent. They did not. And in the process we have lost about 30 months from data lock.
With experience and proper execution, this could have all been accomplished in 12-15 months at the max considering the COVID related issues and a small team.
Given the history of such missteps, I seriously doubt if EW healthcare is going to risk a significant capital with this team. Even if they do at some point, they will squeeze the hell out of the management and would want much higher discount than what they are currently selling the C shares for.
I doubt we see $2-3B market cap again until we receive FDA PDUFA dates.
Never questioned the science and the support of KOLs. I applauded their efforts around JAMA Oncology when it was published. But there are quite a few pharma companies that have good product and ph 3 data, but they remain a boutique operation due to stubborn and inexperienced management crew that simply are unable to do the right things at the right time. And therefore cannot build trust and credibility amongst big investors given the sketchy history!
The reality is they are not able to bring big investors that see the value of the ph 3 data as well as the progress they have made and importantly value the company over a $2-3B market cap.
Yes for those that still trust this management or want to get in & out for quick profit, it may be best to get in after the news. I expect shorts will sell on the news again as incompetence of this management continues to get exposed as there will be no guidance on the most important milestone - FDA.
Already approved by international partners. Doesn’t look like MHRA is likely to approve in 2023?
Yes down if you sell it. A lot of good opportunities will open up as markets correct and it would be prudent to move more of NWBO money in those big names and increase investment there. Can’t trust this management to consistently deliver growth and increase shareholder value.
How long do you trust these folks with their history of fumbles and missed timelines? The next excuse will be markets are bad! But if you are not proactive and do not execute in a timely fashion, then the whole universe conspires against you! Looks like dead money for a while with no progress on FDA or guidance anytime soon.
Good luck! I wonder if any of the warrant holders or big investors have seen a 5 year business plan or vision presentation from LP et al.?
Again, yesterdays SP movement correlates nicely with the 1.65M increase in OS!
Even MAA application acceptance and eventual approval will turn into a commercial execution battle. It never ends. Unless you deliver consistently, the street and naysayers will continue to question. Nothing new. Ultimately, the management has to convince the shareholders and investors on the value. They have not been able to do that for well over a decade. And why is that? Because they have botched on execution and/or the street does not trust them to deliver growth in the future. It’s super disappointing that there is no guidance on FDA even 30 months post data lock.
I wouldn’t be surprised if shorts take advantage of the MIA announcement too. I don’t know at what point the loyal management supporters will force LP and LG to pass the baton to dynamic, experienced leaders?
The below two points I agree with. But the SAP needed some careful planning and support from the community. Overall, the longs have been trained to accept mediocrity in performance from this management. Small team and manipulation is always the answer!
“The delay for the PIP was absurd. They could have started that process whenever.
The delay for the MIA is absurd. They could always have used CRL or some other CDMO instead”
Me neither. Never heard of them.
Good luck with your exit strategy and hopefully it won’t be too long!
“Outside of the MIA, there won’t be much in the way of value from approvals in the foreseeable future.”
Correct. It’s dead money for a bit. The fact that they have taken this long to get MIA and that everyone is expecting it, there is no surprise element anymore. In fact, I think the traders and manipulators on both sides will use it as an opportunity to sell the news!
FDA BLA news or big, credible investor coming in at a much higher floor are the only pieces of news that has the potential to move this stock significantly higher. However, I don’t expect these milestones in the next few months. Even if an investor such as EW comes in, they will get in at bargain prices. They have a history of doing down rounds.
Or folks will be disappointed because it becomes increasingly clear the path ahead is going to be more time consuming than what most folks anticipated. Is sell the news coming!?
Agreed! He projected around $80 million from specials revenue last year. Even this year, we will be less than 20-25% of his projection for last year. Not just that, he has been wrong on many other aspects over the years.
Having said that, he appears to be connected to the management and some of the warrant holders. My sense is they all work in synchrony to get retail to buy while they offload part of their holdings. Rinse and repeat!
My strategy has been to be extremely cautious when these guys come out on social media and start talking about specific milestones, timelines or partnership like news. None of these things will come true (at least not at the timelines they project). The management could get in serious trouble with insider trading/info!
It’s A. Don’t think buyout is coming anytime soon. At least another 2-3 years as best case scenario, but even then a lot will have to go right in terms of execution and building credibility amongst investment community….and I don’t trust this management to not fumble over and over again during these years thereby turning off potential buyers!
I agree with you. In fact, they should have Advent marketing team do this work for them. They are fairly good at both web and social media. They can build their U.K. website in time for the launch of the commercial product as soon as MHRA approval comes through. I bet someone from Advent team in collaboration with a web designer will do it in about 4-6 weeks with less than $50-100k total cost.
Unfortunately, I will have to agree with you on this one!
LOL. Excuses never cease to amaze me.
They were all working on the publication and MHRA application over the last 2-3 years. How dare we expect anything else from them?
Another sell the news event coming? Let’s see how this pans out. I wouldn’t be surprised if the blame is placed on manipulators again!
Good for you!
I don’t doubt the support of KOLs and that’s the only reason I am still invested in this. But that doesn’t take away the responsibility of the company towards the patients and the shareholders. And importantly not how you run a successful, thriving business.
The most basic thing they could have done in the last few years is to have good web presence, if they really were proactive and cared about these details. Also, prepare for a U.K. website. They could have hired couple of interns or consultants and gotten it done in less than $50-100k expenses in a few weeks.
Once they get U.K. approvals they can go live there with marketing, patient resources, etc on their website. But that’s too much to ask and expect from this group. As PM pointed out earlier today (in the context of the loan terms), they just seem to be lazy. On the other hand, look at Advent. They have an excellent web and social media presence.
I will also tell you from my experience in this world that these clinicians also move on at some point. You got to continue to innovate and make meaningful progress. The lure for getting involved in exciting new trials with new clinical research funding can not be dismissed!
LOL. Good luck! I hope the SP reaches your target zone soon.
I am playing on house money, but still the opportunity cost and execution from this management leaves a lot to be desired. Not to mention the lack of transparency from the management and the BS thrown around by their digital media army. It bothers me even more because I have been deeply entrenched in this world for over 20 years.
Their attitude towards business is well reflected by their crappy web presence as a quick and dirty example. Look at their website for instance. Where will patients go to find info about this therapy once approved by MHRA? Just simple things like that tells you all you need to know about the management group.
Everyone predicted publication, TLD, MIA and other milestones much sooner too…but we will see…
I don’t agree with that prediction. I see it as a pump. We will not hit 50 patients per month in 2023. Thermo even forecasted commercialization in U.K. by end of Q2, 2023 a few months ago. He was obviously wrong. They haven’t submitted the application yet. The 5 month clock will start after submission. And that too is a perfect scenario! Given the history of this management, I’d expect that some issues are discovered with their application and they lose couple more months!