Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
MHRA approval won’t happen for another 6 months, but let’s touch bases on your share price predictions in 2 months! I’d say there will be no FDA BLA submission in Q2. The only application they will submit in Q2 will be MHRA.
No reason for big investor to pay 2-3 X of the share price for an OTC stock with the history of this management team coupled with the market volatility and tight financing we will be seeing in the coming months.
Again, 50 patients per month volume will not happen in 2023. Even if they set the price at $150k that won’t happen. But again, they won’t lower the price to under $200k as it sets bad business precedence and will make their life difficult extremely difficult with reimbursement negotiations in the future. It would be a bad business move!
50 per month without reimbursements is highly unlikely. Not happening this year guaranteed!
We need a big, credible partner right away who builds up a significant position at a much higher floor. My prediction is they bring in an investor after MIA and/or MHRA submission but they will come in at a discounted price (around 50 cents). Financing is going to get increasingly difficult over the next 12-18 months so any new investor that come in with significant investment (around $50-100M) is going to squeeze NWBO management. Can’t blame these investors for managements ineptitude, missed timelines, delays, etc.
We are on the same page!
Yeah, I just saw that too! Johns Hopkins and Cambridge.
Agreed. Just look at their PR history around specials manufacturing certifications over the last 18 odd months. The reality is they treated less than 20 patients last year on specials. A 12 to 15 X increase would be needed to get to 20 per month.
Importantly, the hype and focus around specials revenue suggest that chances of RA and reimbursement in U.K. this year is getting increasingly slim.
Hype around specials revenue by Thermo! ;)
I agree. Specials will never get to 50 patients/month. Without RA(s) & reimbursement(s), it will be extremely challenging to get there. They will shout from the roof top if they were generating significant revenue. The number of PRs from the company around specials manufacturing processes and approvals about 12-18 months ago is a prime example. They hyped that up!
Again, these statements suggest that RAs and reimbursements (even in the U.K.) are at least a few quarters away.
Why do you expect the management behavior to change now when it hasn’t in the last 10 odd years?
My worry is the likes of Dr Liau, Brem, Toms, Musella, etc get frustrated with the slow progress from NWBO management. I don’t think we are there yet but if there is no progress on BLA in the next quarter or two, I would be extremely worried.
I said this a while back that their compensation should be tied to milestones and shareholder value creation. They will stop giving excuses and playing victim card then!
The two folks that does deserve credit from the management and board are Marnix and Naved.
I don’t know how they will be able to uplist in the near term.
Their best bet is to execute on FDA or big partnership, which will build some credibility and trust. I do believe something seems to be holding them up on the FDA side of things other than manufacturing. They have not been transparent on that piece. Otherwise, no reason to not go after FDA before U.K. with 10 X the revenue impact. All this notion that FDA is biased and corrupt is bogus.
Balanced response! I don’t think MIA and MAA submission/approval news alone will get us to $2 either. We’ll need more such as partnership or FDA BLA acceptance news to get back to $2 and stay there long term rather than a quick pump and dump cycle.
No one would dare to manipulate the stock price on an ongoing basis if you can consistently deliver milestones in an aggressive fashion. Execution, execution, execution! 30 months post data lock and no signs of FDA BLA or formal guidance from the company. The problem is the street does not trust this management team to deliver consistently and rapidly.
Unfortunately, that’s unlikely to stop for some time with this management at the helm and their rich history of fumbles, missed milestones and timelines!
But opposite impact on share price! ;) Will we see the same pattern, increased awareness but downside price action? That would be very concerning!
Lol, same thing was said about TLD and high impact peer review paper. We have all seen how that turned out! ;)
Agree 1000%. Outside FDA, they will remain a boutique shop and not draw serious investor attention.
They have likely had a major finding during the inspection and as usual they keep shareholders in the dark. Some of their social media army is trying to create a positive spin around this as usual!
I agree I don’t expect anything this month given their latest financing.
Either way, this arrangement indicates they don’t expect significant share price appreciation in the coming weeks. Otherwise they would have waited a bit to sell preferred C to finance?
I don’t agree with your take. It will get approved by all RAs. 70 of the top neurosurgeons in the US and Europe support the data. There is an unmet need. And it’s safe!
However, I can not place the same trust in the integrity of majority of the members on this management team as well as their execution skills. They are also running this more like their private company with a laid back academic culture rather than a driven commercial organization.
“I have very much lowered where my exit will be from this stock.”
Make sense. You have to play the game the warrant holders are playing and sell on the next pump because I don’t think this management will be able to execute fast enough and deliver consistent growth in shareholder return.
LOL. It’s not about LP v/s anyone on this board. However, with everything that LP knew, you don’t make statements such as U.K. approval imminent 30 months ago! That was obviously a lie!
It’s weird that LG lied about U.K. approval when PIP was not even submitted. Forget about MIA!
Unfortunately big, credible investors or big pharma are not trusting this management to deliver despite good data! ;) So many companies with great product remain a boutique shop because of bad management and execution.
How stupid of them to not know that PIP and MIA were required before U.K. can approve a product? In their heads, were they thinking they were a big pharma with abundant resources when they made those claims?
A reasonable measure is what the market values the company and its forward looking guidance. Not what you and I think. And the reality is we are trading at 65 cents! The management has failed to bring big, credible investors or big pharma partner that value this company much higher than what we are currently trading at.
“Start providing the next 1 to 5 year investment outlook!“
That’s good business practice and does not apply to our management because they are too busy pushing the can! ;)
Agreed. Hint - Big Booze show! ;)
Longs haven’t given up on approvals, but longs have accepted the fact that this is dead money for a while. Until FDA BLA news or big credible partner comes on board….UK news has been expected for many months now so nothing new. Plus UK is less than 5% of the global pharma market so will not lead to significant price appreciation.
But my shares are available at 1.90! ;)
Why would anyone buy the C shares at $2 when they can buy it at .65 cents now? They have been selling C to a few investors at these level so why wouldn’t they offer the same deal to EH of EV? In fact, EH would negotiate better pricing given the amount of capital her firm puts in.
So they are wasting time talking to US CDMO?
If you are correct, then they should apply to FDA first and not MHRA. US is almost 10 X the market size of U.K. from a revenue perspective. Something doesn’t add up! ;)
Haha, such a BS artist! Not sure why he is on the payroll!
I don’t think FDA approval is likely this year. There is no commercial manufacturing infrastructure in the US yet. They have opened up contract negotiations but these things take time. I doubt we will see BLA submission until Q3/Q4 at the earliest. And that puts FDA approvals around mid next year.
I don’t think a buyout is coming anytime soon. If a big pharma was already talking to NWBO and a deal was in the works (pending approval) they would have handled US manufacturing differently. NWBO wouldn’t have started discussions with US CDMO as they indicated in the last report. Big pharma would want to use their own manufacturing facilities for quality control, IP protection (Flaskworks), and margins. My sense is buyout will take a while. NWBO will have to consistently prove that they can scale and be profitable over a few quarters before a big pharma jumps on it.
No reason to stop, lol!
Agree with you. On the contrary, it could be sell the news! Even MAA news will be perceived as meh, IMO.
Outside a big pharma partner or FDA BLA news (which are unexpected and significant), I don’t expect a major pop that will stick. JAMA publication, TLD, PIP approval, multiple presentations from LL, KA, and others have failed to create the needed excitement and investor interest even though they were supposedly steps in the right direction. The reality is that street doesn’t trust this management to execute and deliver value in a timely fashion. Or the management is unable to convince the big investors on the true value we deserve.
The credibility a big pharma would bring in with such combination trials would indeed be well received, but let’s see if and when they come through on that promise. LP also said at a conference in summer 2020 that they can’t wait to release the data with the community. And it only took over 2 years! ;)
Gary, what’s really tiring is management’s BS, incompetence, and inexperience with the regulatory and commercialization. At 29 months post data lock, a well run company would have had multiple RAs and great quarter-on-quarter commercial revenue growth in tens of millions of dollar. We are still a year out from that at best. Their lack of hiring on the commercial side suggests they don’t expect meaningful traction for another year or so. There might be an occasional pop in share price when one of the major milestone is achieved such as FDA BLA acceptance and PDUFA date, but I am not sure if it will be sustained for an extended duration because the street doesn’t trust this management to deliver consistently and aggressively.
Agree 100% with your take. There’s always an excuse! 29 months since data lock and no regulatory submissions/approvals is the primary reason for our weak share price. The markets don’t trust this management to deliver on regulatory and commercial objectives in the near term. Basically, they can’t get even the hard core fan base and existing investors like Thermo, Bigger, Hefner, et al. to buy more in the open market at the current price and be excited about what’s coming.
We will both be here post MIA. My point is if we are lucky we will spike by 10-15% or so but will give up all the gains in the next week or two. Again, the blame will be pointed to manipulators and no one will question the management for their inability to bring top notch investors on board at higher valuations. Why would any big investor buy shares in open market when they are offering C shares at around 65 cents or less?
I agree MIA is baked in. Everyone is expecting it. It’s more the unexpected (such as Flaskworks approval or FDA BLA news or big pharma partnership) which will move the stock significantly. Even MAA application news will likely not result in any meaningful price movement, IMO.
A bunch of folks are increasingly tired of the wait and are looking at offloading some or all of their position on the next spike, but not sure where the buying will come from. They do not seem to get any traction with the big media houses or big investors!