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I wonder if LL gets a few minutes to talk about her work (virtually) in front of other Asian Hall of Fame inductees and organizers? There would be a number of filthy rich folks at that meeting and her acceptance speech could spark some interest in our technology!?
For example, look at her Wiki profile - https://en.m.wikipedia.org/wiki/Indra_Nooyi
A few years ago, she was ranked the second most powerful woman by Forbes. She is a former CEO of Pepsi and sits on the board of Amazon and IBM. She is also invited to join the board of Philips Healthcare.
They will likely change this landscape. Tesla was also the first and only manufacturer a few years ago that took advance deposit from customers to book their car which wasn’t delivered months after the registration. They changed the car buying experience completely! There is always a first and they are often the game-changers!
On the flip side, if NWBO doesn’t deliver on FDA approvals in 2022 (after having withheld material info for so long) lawsuits from retail investors are likely. To me, this shows the management is super confident in what’s coming!
I’d like to know if there are companies that saw more than 500% appreciation in one or two business days. The company must have had a market cap of $1B or more before the rise.
I agree with your take! The only exception could be if there is a leak at SNO from one of the advisory board members. With an on-site meeting, I wouldn’t underestimate the possibility of spilling the beans after a few drinks! ;)
LOL, you and Poor Man crack me up!
This could be their normal yearly pattern. Perhaps things slow down during the summer every year? We might want to plot this for 2019 and 2020 to understand this better?
I hope you’re right, and we become the Tesla of biotech! However, when markets tumble it will take everyone along for a ride regardless of whether you are Tesla, Apple, Microsoft, etc. Tech and high flying stocks get impacted more so than some of the defensive biotech stocks, but there will be negative bias…valuations come down as there is less appetite for risk taking….generally, the forward P/E multiple they trade at comes down significantly….
One of my concerns is market starts tanking given the shift in Fed’s monetary policies and we are still waiting on the 1 yard line! And there will be yellow flags all over the field and we start moving backwards. The upside will likely be capped. We score a FG instead of TD!
LOL. Unfortunately no more buying opportunity for me. :(
No news at SNO is baked into the SP, imo. So I don’t think we will see a move either way unless we run up between now and SNO in expectation of the news, which is quite possible! In that case, it might come back down to the current levels in absence of any major catalyst at the conference.
I think that’s probably what is holding up publication. Lancet or NEJM likely would like to see that formalized into an official document before the reviewers give their stamp of approval given the changes in end point and SAP. And it’s likely that LP will not release TLD until that either. They don’t want to mess with FDA! ;)
LL is probably just as frustrated with FDA!
Make sense!
Awesome, thanks! Did you get a sense that they may be working on BLAs behind the scenes?
I also feel like if the data was ambiguous LL wouldn’t have gone on that road trip in the spring to convince scientific community on the value of ECA.
“LL said somewhere that you can't patent dendritic cells. You can certainly patent the processing and that is the value”
Yes LL did mention that in an interview. Ultimately, this will be a technology race much like the EVs. And she knows that big pharma (Merck?) is going to get involved! :)
I think in the same interview she mentioned about creating an Uber like business/delivery model for personalized vaccines, which was quite interesting too.
LOL. I do not own shares of CLPT. Although I know senior management including the CEO well as we all worked together for the same company for a couple of years. However, I see much stronger potential in NWBO given our broad technology platform!
Well articulated. They are a terrific team, with the right mix of youth and experience!
The SAB is incredibly accomplished and that’s another strong reason I have continued to stay patient. However, none of them have written BLAs before, unfortunately! A lot of this work ultimately fall on the shoulders of company personnel or external consultants. These guys on SAB have a grueling day job!
The fact that they are not updating clinicaltrials.gov website tells me they are still working with FDA to sort out some issues. And they are worried about offending them if they update this prematurely.
Again, this is where experience and relationships with regulatory agencies matter. No one on the NWBO team has done this before and they would certainly benefit from a regulatory expert on their team who can provide structure to drive and accelerate these discussions. Would we be in a better position by now if we had such a person? I think so! Again, we don’t know what’s going on behind the scenes, but at the very least I am hoping they are consulting with someone who has been there and done that before successfully (ideally someone from Merck’s team helping them behind the scenes or less ideal an experienced outside regulatory consultant).
My question to some long, loyal shareholders on this board - at what point do you question management and their actions or lack thereof given no one really knows what’s going on behind the scenes except they are working really hard in all earnestness to cross the finish line!? Ask yourself honestly when they locked the data in Oct last year, did you expect TLD and publication to take this long? Very likely our understanding of the problems/challenges evolved as time passed so we tempered our expectations. How long will we continue to do this? Or we are comfortable letting them do their job as long as we continue to see some breadcrumbs and outside evidence of things moving in that direction even if we go into Q2, 2022, and beyond?
By the way, I have been invested in NWBO for over 10 years because I believe in the science. Although 90% of my investment has been in the last 18 months. I don’t plan to sell until TLD, but as a shareholder I can totally question management’s action when I feel strongly about certain things. For me that trigger was slow progress on UK certification. We don’t need to get defensive and question motives. Otherwise there is no difference between FUDsters and folks that constantly support management to protect their own investment.
Yeah, they must have agreed on some milestone based valuations.
Our acquisition was at a smaller scale and despite that the process I outlined was started 12-18 months prior….so I agree Merck ought to have started this journey a couple of years ago, if not more.
In one of LL’s interviews, I think she mentioned how this personalized vaccine industry need to have an Uber like business model to be really effective. That was an interesting comment!
Agreed, it better be at least a partnership if not a buyout in 2022. They haven’t put any pieces in place to set up a thriving commercial entity or for that matter even an emerging biotech entity that is in the process of revealing positive ph 3 data. Part of me thinks LL also knows a big pharma is going to get involved and that’s why she has stayed patient with the NWBO team. Otherwise she is smart enough to realize from what she has seen over the years that even if she puts in all the energy to help them convince scientific community and regulators on the use of ECA, the NWBO management will struggle if they stay independent. And decades of her work will not have far reaching impact.
When we went through acquisition of my previous company by a big medical device company, I personally took the M&A team of the acquiring company to our KOL Neurology groups a year in advance so they can do their due diligence. And they kept on interacting with these KOLs. I am sure LL has been involved in this process. This is the most optimistic I can get at this point! ;)
I don’t think they are lying. It’s incompetence and lack of experience more than anything else. If they were lying all this while, I don’t think the likes of LL, KA, and their esteemed advisory board would stick around this long. They wouldn’t put their reputation on the line.
They need help on the commercial execution side and I am afraid these KOLs scientists and clinicians can’t help them there because they do not have industry experience. These two worlds (academia & industry) while intertwined they have also significant differences in the way they operate as well as the skills/experience required to be successful.
I respectfully disagree. I have been working with the neurologists, neuroradiologists, and neurosurgeons directly on introducing new medical device technologies for their workflow for way too long! How many of them review or keep up with the (top notch) publications on a weekly/monthly basis? Very few. It’s not just patients and doctors, the administrators need to be involved, reimbursements need to be worked out, etc. If there are no resources to hand hold some of these processes at mid and low tier hospitals, it will never get done! The access will be limited and slow. And don’t underestimate the power of big pharma reps that have relationships with these admins…they will work their magic to resist change because it displaces their product.
Also, there is so much information on social media and online. How do you sift through all of that and decide what is right and what is not?
Before reorganizing, the least they can do is update clinicaltrials.gov. The stubbornness around it is mind boggling to me. If FDA has fully accepted their new endpoints (as quite a few here claims) what is stopping them from doing this? Especially now with all the evidence that has piled up over the last few months….
Reorg:
I’d get a more dynamic business development person who can convince LP on the merits of a buyout or partnership. Often times to solve very difficult problems, you cannot do it alone and must appreciate teamwork, experience, and urgency around execution. And sometimes you need to give up some control for the greater cause because ultimately you will get to the destination with a greater degree of certainty and rapidly and thereby creating more value for everyone involved.
Get a regulatory expert with successful BLAs to his/her credit, having worked with one of the big pharmas.
Build a small team around these folks.
Also, I wouldn’t underestimate the need for sales and marketing resources. Again, this whole notion that because we are NWBO and have the greatest ever product in DCVAX with minimal to no side effect is not enough to make in roads. Even a blockbuster product like Keytruda with billions in annual sales coupled with the credibility of a world renowned organization like Merck needs a huge sales and marketing team to constantly outreach and expand sales. A top notch publication with dozens of KOLs will not replace this regardless of how good your product is. You literally need to go out there knock on the doors and build relationships from ground up.
BioNTech and Pfizer partnership is a perfect example of how a relatively small company with ground breaking technology can leverage the experience and resources of big pharma to accelerate their go to market strategy while creating a win-win for everyone! Often times CEOs and management of small companies are extremely stubborn and don’t appreciate the value of such partnerships and timely execution.
Indeed, time is money! If they can’t get the damn certification on first attempt without major non conformances, I seriously doubt their ability to execute on BLAs. Many companies I have known and in fact couple of companies I worked for in the last 20 years that were about the same size as Sawston have been able to pass such audits in first go!
All of these excuses about look at how many biotechs fail and that we are still afloat is just not the right paradigm in my mind, particularly with so many missed timelines & failed promises over the years. If we aspire to be one of the leading oncology companies then we ought to measure ourselves against the best and most successful biotech companies.
Again, I trust LL and believe in the science…but she is not going to come to our rescue when it comes to getting the drug to the market and making it commercially viable. NWBO team will need to accomplish this and at this point I have limited confidence in them. Pretty much all the members of the management team are beyond retirement age or approaching retirement, and have never filed a BLA or successfully launched a drug in their lifetime….that’s not a recipe for success if you were to ask me! Hopefully a buyout or partnership is in the works!
100% agree.
They could have gotten UK manufacturing ready if they were planning ahead, for example. That was not tied to the data and regulators. My point being they lack urgency and are not good with executing in a timely fashion….they have repeatedly missed timelines after timelines….Stop giving excuses because their job as leaders is to find way a way to navigate around difficult problems and find solutions or have contingency plans in place.Tesla doesn’t take chip shortages and supply chain bottle neck as an excuse….instead they work proactively to find solutions where they get their hands on whatever supply there is before anyone else….
I know all of this is easier said than done when you have limited resources but again they have themselves to blame….And why are you almost always defending them? Rather then challenging them to think creatively and take responsibility….I have a million shares between myself and a couple of my friends and family members (perhaps not as much as some of the posters on this board) but we do need to call them out when it’s appropriate!
Agreed on all points. They probably went extra conservative this time around in their PR, and it’s likely they may get final approval and certification before the end of the year….Although I am fairly certain it’s not happening this month for sure….You can blame COVID as much as you want and there is obviously truth to it with the delay in inspection, but then you don’t set expectations in an aggressive fashion and also ensure that you utilize the additional time you have on hand to put out top notch work….this way, it gets approved in the first go and does not require additional back and forth when the visit finally does happen…. Either way, it demonstrates their lack of experience with so many missed timelines, lack of urgency, and not understanding the intricacy/requirement of each step…. that’s why I feel like a buyout is needed to help take this technology to the next level in a timely fashion and serve the patient community…we may be here next year at this time and we may not have any approvals yet if they go alone…
I am not arguing against their genuine intent and strategy of expectation management….but the PR tells me that they have some non conformances they will need to address….and that the inspectors did not give them a verbal approval on the last day….hence there will be some back and forth to address non-conformances….generally if the inspectors notice a few minor non conformances, they would still give a verbal approval to key officers of the company on the last day and a formal certificate is issued the next week regardless of whether those minor non conformances are addressed or not….in this case, they clearly did not…how long it takes Advent to address these points is just a guessing game at this stage based on what was found and the amount of work that may be needed…typically, these are not not fairly quick turn arounds, say days…it’s rather weeks….so that’s why I feel like it’s not coming in the next week or two….
Unfortunately, I will have to agree with you on this regarding their PR language. That’s what surprised me and added my frustration with this management.
Manipulation by MM’s?
I hope I am wrong! It’s certainly different than what I am accustomed to with ISO and other regulatory audits, but we will find out in the next week or two.
I don’t think you’re right on this. I have plenty of first hand experience in medical device space in terms of how it’s done. Perhaps GMP certification conversations are different, but I doubt….it’s not to say this will take months to get a formal certificate, but I just don’t expect this in Nov….
That’s what I’d expect….within a week or less…that’s been my experience over the years with various external audits in the medical device space….I think they found some non conformances during the site visit that weren’t deemed minor and needed to be addressed before they would certify…otherwise they would have verbally told key Sawston folks on the last day of the site visit that we are going to issue a formal certificate but you will need to address these minor non conformities before the next renewal…
I hope a deal is in the works because it would be unfortunate for the patient community. I don’t think this management have the experience, skill set, and resources to scale this up in a timely fashion. At least they have not show this in well over a decade.
As someone said earlier, I’d be pretty upset if they didn’t make any meaningful progress towards getting them qualified for accelerated approvals or getting their BLA application ready while they have been waiting on the publication for the last year. It must all come together now (and that too this year) to build investor confidence, otherwise I am afraid even great data and publication wouldn’t be super convincing in terms of management’s ability to accomplishing the the next steps in a timely fashion by themselves.
I’d be surprised if Sawston certification comes through next week or even this month for that matter given how they worded the last PR. They made it sound like they expect to address some non conformances and that will take some time. Typically with such site visits, the inspectors would verbally tell the company officers on the last day before they leave if they have approved or whether the company will need to address any major non conformances before they will consider granting a formal certificate. At least that’s been my experience with British Standards Institute (BSI) on the ISO audit side. Not sure if the agencies take a similar approach for GMP certification as well.
I think the lost opportunity cost will start to wear on quite a few anxious retailers if there is no TLD & publication this month or early next. A lot of folks including myself are in this because of LL & KA as well as the underlying technology and not so much because of the top management. They haven’t done much to convince otherwise! LL and the technology alone cannot make them successful. There are so many other pieces that they need to get right to be successful commercially. In particular, we need the top management to show with their actions that they can get the job done and scale this up. Time of execution is of essence!
Why haven’t they gotten a successful executive or two with proven track record and experience in successful BLAs to join the team to help them navigate this? That could mean one of two things: a) they are not that competent and there is lack of urgency OR b) they don’t plan to stay independent for too long.
Given the KOL advisory board they have formed over the years and the fact that LL and KA has stuck with them for well over a decade tells me that they do trust the management to get the job done even if it’s not as quickly as they would like. So it must be point b, where it’s being set up for a buyout post approval.
You’re probably right, but what I don’t understand is why they wanted to go after UK MHRA approvals first? This is what Les mentioned couple of times on that big biz show last year. If FDA had bought in at that point then why not go after FDA first or all of them together through project Orbis? Something in their strategy changed between what they were saying and planning in Aug-Sept and Oct 5 PR.
I don’t think Flaskworks is going to get approval this quickly. In the May PR, they referenced it as a prototype, so it will be a while before that becomes an approved product and the workflow/process gets certified. Working in the medical device industry for the last 20 years, I am assuming Flaskworks will need to get FDA (410k), medical device CE certification separately as well before it can be deployed at a certified manufacturing facility. Not sure how this works in the context of the equipments that are used at the CDMO….the fact that Flaskworks is never going to be in direct contact with the patient, 410k and medical device CE certifications are not needed?