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Great analysis! I do believe we could follow similar trajectory or higher given our platform is broad and the fact that we will have NEJM article to cement our findings!!!
That would be silly in my mind unless they are still waiting on the updated FDA guideline document. Either way, this has the potential to feed into the bear argument, but let’s wait and watch how they package and release series of good news!
I still believe the very first thing could be the update to clinical trials as the goals referred to in both the TLD statement and Journal should be what's in clinical trials, but it all might happen simultaneously.
I think it will happen on the same day for max impact. Also, the FDA guideline document may be finalized then. We could fly a few hundred percentages on that day! And it’s finally coming in Q1!
Yeah, it sounds like we will have our TLD+publication this quarter!
Totally. Merck takes full control before the end of the year.
Why can’t they just activate contract with CRL? They have the scale and the credibility. I don’t think manufacturing readiness is a strong reason in my mind to keep delaying anymore. If they dangle Flaskworks certification carrot now for not releasing TLD+publication then that strengthens the bear argument and I for one will not be around because I don’t believe in that strategy. However, I don’t think they will do that. They can always work on Flaskworks certification in parallel or post approvals as phase 2 expansion.
Good point, but the same can be said about the publication route!
I’d expect that they would have had pre-BLA meetings already and if things go well, the BLA is submitted this quarter as well. That Lancet article came out in early October. I’d think the company must have reached out to FDA to schedule a Type 2 meeting soon after that.
We will have a buyout near the end of this year. That’s the best go to market strategy! ;) And both the Linda’s know this!
Agreed. I think every investor should set some timelines and goals in their mind. For me, it’s end of Q1. If they do release TLD + publication before then, I will stick around with at least 50% of my investment to see how the rest of the year develops. And in that case, it’s highly likely they will be acquired before the end of this year or on FDA approval.
Sure, highly unlikely though. The likes of LL and KA would have sensed it over the years is sort of how I look at it! They would have not made those presentations as late as April-May 2021!
Exactly, thanks! Such small biotechs with tens of million of market can fly 400-500 percent in a day. But I have yet to come across one with at least $500M base market cap that would then fly to a couple of billion market cap in a span of one or two days. Maybe I am wrong or ours will be different if the results are truly ground breaking as we expect and we get the media attention we deserve…also if there are indeed naked shorts as some claim then we could see what we saw with AMC, GME….but I personally don’t think we have naked shorts anymore…
Understood. I have some concerns regarding their missed timeline projections over the years as well. That has certainly impacted their credibility for sure. If they dangle any more carrots such as Flaskworks certification, etc for not producing TLD+publication in Q1 then it’s time to get out (at least for me personally). But I don’t think that will be the case here. We are very close, imo.
Either way, I don’t think raising the same questions over and over again helps anyone. Frankly, I don’t think the management will deter from their plan (whatever that may be) if you and I with our million odd shares cash out at any point. I will still hope and pray they succeed because the patients need it!
Most members of the executive management team of NWBO are well beyond the retirement age and they are fairly wealthy. So they are in this for a larger cause and I firmly they will pass the baton to Merck within 12 months or so. I don’t see them continuing much longer! They will certainly not be around to run another trial! ;)
Can someone point to a biotech company with at least $500M market cap valuation that may have then jumped over 400-500 percent in a day or two post major event/announcement?
Just curious to understand how high we can fly the day we reveal TLD+pub.
I have raised some concerns as well, Sir! However, to their credit they are working with the top notch neurosurgeons and oncologists in the world, which is extremely rare for a tiny company such as NWBO to have such key opinion leaders on their side. Not just LL and KA but the experts they have gathered on their SAB is commendable. They wouldn't stick around for years and years if they didn’t believe this will get across the finish line. The other thing you ought to consider is the political influence/network that LP may have. It’s not easy to get the likes of Cofer Black on their board. These are some of the major differences between say a company like NWBO and CVM (in addition to our broad and safe technology).
It always takes longer than anticipated when you are developing and commercializing a disruptive, game-changing technology. It’s an uncharted territory and you discover many challenges along the way that you didn’t foresee. And not to mention all the skeptics and competing business interests.
I do believe we will see TLD+publication this quarter. If not, I am out as well and I will wish the team all the success!
It’s super interesting! Will the Jan edition of NEJM Evidence also result in FDA finalizing their guidance document around the same time? This could also open the doors for NWBO to finally update US clinical trials website with new endpoints in the next few weeks?
Also, interesting is that Dr. Bosch is presenting on Jan 19. These series of events in Jan have the potential of strong and exciting catalysts we have all been waiting for!
Why would UK and EU accept new end points then?
I agree we are fairly derisked at this price level given that UK (and hopefully EU) approval(s) will certainly happen this year. Regardless of which way the FDA goes, we ought to be sitting at least at $2-3 SP with everything we know so far. So I believe our downside risk is extremely minimal unless we have a big crash in the stock market, which I don’t see happening in the near term.
I will not be around if there is no TLD by then! ;)
What we do know is that UK and EU has formally accepted the new end points and that it’s a win in their books! If the US clinical trials registry is updated with new end points, will you agree that it’s a win with FDA as well?
Agreed.
I work very closely with top neurosurgeons and neurologists in US and Europe (although not for oncology work), so I am quite keyed in to how Omicron is impacting elective surgeries again. We just had some of our visits over the next couple of weeks postponed at Mt Sinai and couple of places due to Omicron concern. So Q1 will be slow. I forecasted Q1 rev of $3-4M a few weeks back. Either way, I believe we will be over Ex’s $2M forecast for the year in Q1 despite COVID slowing down new patient surgeries.
Your prediction is absolutely wrong and doesn’t make any sense.
We will be close to $25M in revenue from Specials program this year. The first half of the year will be slow, but as the word spreads about our phenomenal results, publication as well as return to normalcy in a milder COVID world, we will see a nice ramp up in the second half of this year.
I agree with you. That’s just the reality on the ground, unfortunately, whether we like it or not.
Also, agree with your earlier post about the potential of specials program in 10s of million rather than 100s.
Having said that, I do believe we will have regulatory approvals this year. Very likely TLD+publication in Q1, RA in Q3/Q4, and buyout around the end of the year.
The fact that it has taken this long to release TLD+publication makes me think they strongly believe FDA is on their side too, but they are being extra cautious with FDA and letting them take care of their internal processes and red tapes.
Either way, from a valuation perspective we ought to be close to $3-4 SP with UK and EU approvals. FDA approvals doubles that valuation in my mind.
Indeed.
Agreed. Also, if they intended to stay independent they would have at least started to put some job postings for sales, marketing & business development team, considering they are sitting on the cusp of a major disruptive technology reveal and imminent change of standard of care. Companies start hiring months and months in advance to start training their staff. I’d have expected them to start making moves in this direction in UK and EU region at the very least given that approval there is 99% certain! Again, speaking from personal experience in neurology space and having gone through an acquisition few years back. They are doing nothing!
I wouldn’t trust anyone that says they don’t need a sales/marketing and business dev team to promote and capture market share for DCVAX-L regardless of how good the results and technology are both in terms of safety and efficacy. Just doesn’t work that way in the real healthcare world.
Exactly! I don’t think they will go on much longer. I think even LL knows that Merck is going to acquire NWBO.
I still believe there is acquisition on the horizon in the second half of 2022 provided they release TLD+publication in Q1. And we will be acquired in between $15-20 share price…if we don’t get the publication and TLD by Q1 then all bets are off! In that case, I will take whatever I get by end of Q1! ;)
“Marketing can be outsourced and they don't need a salesforce to knock on every doctors door”.
Respectfully disagree. To be able to capture large enough market share, it’s still going to be important to penetrate, build relationships, and keep competitors at bay. You don’t think big pharma is going to fight to avoid displacement of their products? Relationships with sites are extremely important. I have been in this (neurology) industry for almost 20 years and can speak from my experience.
Granted they don’t need to be super aggressive with top tier neurosurgery sites if the results are as good as we expect, but don’t underestimate the need for this particularly with mid to low tier centers.
Interesting watch about the short selling and naked short world.
I agree as well. The fact that some of the top clinicians from Harvard, Stanford, and Johns Hopkins are mentioning DCVAX-L ph 3 trial in their publication is in itself a big victory. Shows how much everyone is looking forward to seeing the final data and new standard of care!
For 2 reasons:
1) to gain access to highly qualified and trained personnel on your own team. These members can also help them expand quickly in other geographies.
2) to allow full control of testing, validation, certification, and further development of Flaskworks. I wouldn’t trust an outside CDMO or personnel for such an endeavor.
Ultimately they will need to bring the costs down (to expand access to care) as well as maintain healthy GM and therefore you don’t want to rely on outside CDMOs in the mid to long term.
We have the same thought process. I don’t care what additional money they (Merck) pay to purchase Advent as long as we (NWBO) get the value our technology deserves. Advent wouldn’t cost them much, probably around $100M or thereabout….when they pay around $20B for NWBO acquisition, another $100M is a drop in the bucket. But this gives them immediate access to trained and experienced personnel that can not only scale the existing facility but also help them to conceptualize, expand, and build out bigger manufacturing operations around the world in a relatively quick fashion rather than starting from ground up. For them, the most important thing is going to be to realize revenue growth as quickly as possible. That’s the best way to justify such an acquisition, otherwise it’s not even going to get approved by their board….forget about analysts and investor community post acquisition….
Regardless of whether they uplist or not, they must be bought out in the next 12 months or so. That’s probably the only way this therapy scales and provides greater access to patients around the world. Nothing that NWBO management has done in the last decade gives any confidence regarding their go to market strategy, credibility amongst investor community, appreciation for timely execution, etc.
Furthermore, LP realizes she simply cannot do this on her own with her current team and organization structure….she is simply trying to extract the maximum value for everyone involved and then pass the baton.
I believe LP hired uplisting consultants as plan B in case the buyout falls through at the last minute for whatever reason.
I agree with your take. They will purchase both. Time is money. Also, access to trained personnel is going to be key early on for any company that is acquiring new technology or getting into a space where they have limited experience.
I think they will be bought out for around $20 before the end of 2022.
Agreed. Not many supporters will trust what they are doing if they cannot release TLD+publication by end of Q1 regardless of whatever excuse and carrot they dangle including Flaskworks! ;)
Wouldn’t it be great if they update the US clinical trials website with the new endpoints soon? That would push our SP to $2 or above within couple of trading sessions. And TLD+publication then soon thereafter would put us in $4-5 range easily, if not higher.
Here’s another recent example of FDA’s commitment to leveraging real world evidence:
https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-inferior-vena-cava-filter-removal-device
I haven’t been reading the message board as throughly over the last 2 weeks as I have been traveling over the East coast with family….but curious why they would hold on to publication + TLD for long when the journal is ready? Doesn’t make much sense to me unless they want to club it with another major milestone that is a week or two out.