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Excellent news! Really nice & creative way to put it. Sounds like we are really close!!!
Happy to order a few dozen of those when we go above $5! You ought to sell them at a premium post TLD/journal!
I think this is extremely positive for NWBO. Thanks for sharing! This highlights FDA's openness towards ECA, setting the stage for our approval! They (FDA) know what's coming from NWBO,LL et al is going to be a game changer. No wonder the team is being extra careful in resolving all the data queries not only regarding the treatment arm, but also the picking the right ECA patient population they present in their analysis. This is LL's hall of fame moment and she won't let us (and importantly GBM patient & science community) down. My 2 cents!
I agree with your perspective as well. That’s why I think a top notch peer reviewed journal publication is so important. I’d hope that the TLD and publication are on the same day! They (bears) would still come up with a hit piece in the next day or two alleging cheating, questioning the leadership over the years, painting LP as the worst CEO ever, so on and so forth.
One thing I have been wondering is whether they may be working on UK approvals in the background (soon after Sawston certification, they could send their application to UK and EU as they have formally accepted end point changes). It’s likely that they receive UK approvals within a few weeks of TLD/publication?
The age of the executives is the strongest indicator they are not going to stick around much longer. Plus the resources from big pharmas with experience and expertise can scale this much more efficiently and faster. The chances of subsequent approvals tackling other disease areas quickly also go up many folds with someone like Merck. Ultimately leading to better outcomes and better care! Who wouldn’t want that?
Also, all the work they have been doing on the patent front over the last year or so is an indication that they want to create a strong patent and product portfolio to pass on to big pharma. If I am a big pharma I want to ensure I am covered on all the patents before I pay in excess of $20B.
And I must add that all signs are pointing to a buyout in 2022.
Agreed. If the data is impressive as we all expect and once we get RAs to approve L, a buyout in the $15-20 range is reasonable in 2022.
Once DCVAX-L is approved for nGBM and rGBM in the coming months, how likely is it that the next trial they initiate for L (targeting another cancer type) uses Flaskworks device for manufacturing?
Nice! NWBO is by far my biggest holding, but have invested in SOFI & LCID as long term investments recently too!
Good one! I wonder what Ex et al. has to say now? ;)
We had a big spike last year on Oct 16 and a day before/after. We touched 2.50. I remember messaging my sister because her birthday falls on October 16 as well. Timing wise October makes a lot of sense for TLD & publication. We may have UK certification PR mid to end of September. And then TLD/publication in October.
It’s clear Linda Liau et al. has had access to trial data in May (probably a bit earlier) as she started outlining ECA SAP during those presentations at Mt Sinai and couple of other places in the month of May. October would be 6 months, and a top tier journal publication typically takes around 6 months.
It took novocure over 2 years from data lock to get FDA approval for their helmet device. That too in pre-COVID days. We are actually doing well in terms of timing…
Totally. I have worked with MHRA on medical device front through some of our customers at top universities in London (UCL, KCL, etc) in neurology space and can attest from a recent experience (less than a year ago) that they are less bureaucratic and move faster than FDA! One of the things I am sure NWBO management is also thinking very hard in terms of how to bring the cost of therapy down. Flaskworks allows that! So it’s important for them to include this in their 5-10 yr vision for how they scale manufacturing and make these treatments more affordable.
I also believe they are accelerating and waiting on Sawston certification before FDA and other RA applications is because that’s where they want to test Flaskworks. They can present a roadmap to FDA and other RAs regarding how they envision scaling manufacturing to meet the growing demand, not only now but also in the future. It’s always a good strategy to test new product at your own facility where you have complete autonomy and control over rather than relying on 3rd party.
I’d rather trust KOLs such as Drs. Linda Liau @ UCLA and Keyoumar Ashkan @ KCL and their decades of experience working in this field day in & day out. They are super confident and firmly believe this is their most exciting and best work to date. Why would I trust anyone else without a scientific background?
By the way, you have companies that take an unconventional path to success. And they often have game changing technology and ultimately become world leaders. Take Tesla as example! They completely changed the behavior of how people think about cars and the whole experience as well as the go-to market strategy!
Advent shows 33 employees on LinkedIn. And they are actively hiring more staff. They will probably be at least 40-50 people company before the end of the year. That’s pretty significant and indicates the confidence the management has on DCVAX-L approval and quick penetration in UK.
Do not forget that we would have another major catalyst in the form of UK site certification any day. So that could catch shorts by surprise. It could as well happen before Sept 11. LP is playing her cards well, and it’s not surprising to see Ex et al. nervous every day!
I agree and well said. I believe this is also why we have posters like Ex and LC on this message board. They are always trying to piece together any clues they might be able to gather from the DD done by smart and creative folks on this board regarding the timing of TLD and other major catalysts. This info is then relayed to their bosses to manipulate the share price. Ultimately, they know that this therapy is extremely likely to be approved by all 4 RAs….but they play the mind games in the interim to extract as much info as they can so their bosses can make some money during this quiet period. At some point, they are going to get caught when that news finally hits unexpectedly with a series of back-to-back events! That’s what keeps them up at night, I guess!
Excellent, thanks for sharing! It seems quite recent. The PR is from last week. UK and Europe seems slam dunk (approvals) for us! We ought to be close to $5 just based on those 2 RA approvals.
LOL! Pfizer/BioNTech COVID vaccine last year!
Will do!
Charles River is exhibiting at the upcoming Society for Neuroscience (SFN) conference. They have a fairly decent booth size. It's going to be on-site in Chicago in mid November. It's the biggest neuroscience research meeting that brings together around 25k to 30k researchers from all around the world. The exhibitors are mostly medical device research companies and this is not a conference for pharmas or big clinical diagnostic and therapies companies such as Siemens, GE, Philips, Medtronics, etc. The participation from European and Asian researchers will be limited this year, but North America will more or less be in full force. My company will be exhibiting there as well.
Anyway, I plan to go up to their booth and try to get some info about their DCVAX-L plan. It would be a perfect time as hopefully the TLD would be out by then....to understand their FDA pathway and North America expansion plans....
I thought this was an interesting article about Melvin Capital Management - https://finance.yahoo.com/news/melvin-t-shake-reddit-attack-205148761.html
In particular, this statement:
“Plotkin also told his team of data scientists to scour social media and message boards to look for shares that retail investors are rallying around.”
Will Ex and LC advise his bosses to cover their NWBO short positions given the strong community here that truly believe in the science, KOLs supporting the company, and the inevitable blockbuster data/publication!
This is what they must have prepared for journal publication too….detailing their analysis workflow… overall, my impression is that the journal article has been in the works at least a few weeks before this presentation….
Interesting read about LL - https://thejns.org/focus/view/journals/neurosurg-focus/50/3/article-pE18.xml
They will publish the data in a top notch journal. We bounce back today and tomorrow. The ASM on Thursday will answer quite a few questions about their future direction.
This is an unmet medical need and I believe FDA will approve this for low risk population given its safety profile. If they can approve Biogen’s new drug for Alzheimer’s, then this definitely deserves it.
Beer beer beer, love it!
Agreed, weak hands gone. I do believe we go back up to $20s before this Thursday AM conference call.
Geert seems optimistic they will win FDA approval. It’s part of their SAP! The conference call with crystallize a ton for all the patient longs! I’d say we move back to $20s this Thu or end of day Wed. FDA will likely approve this low risk group, no side effects/risk.
Certainly helps NWBO. Quite a few of those investors will flock to NWBO, I think. Also, validates LP’s strategy of high impact publication and TLD must go hand-in-hand to avoid misinformation campaign. In our case, we know our new endpoints are accepted by UK and EU, but shorts will continue to spin saying FDA won’t approve. I think we are in good hands!
Agreed. Also, Merck is putting its pieces in place for a significant new business opportunity/deal!
https://www.fiercepharma.com/pharma/merck-taps-longtime-vet-klobuchar-to-lead-strategy-after-clinching-9b-from-organon-split
“ The next step after trial results are released will be seeking regulatory approval, but if manufacturing isn’t ready, then they would have to wait to file. There is no need to rush topline results and journal publication only to wait potentially a year or more for manufacturing readiness. It would be contrary to their stated goal of a crescendo of news events to propel momentum (and stock price) going forward. I believe there will be significant interest in NW Bio’s platform when the results are finally revealed. I think it would be in Northwest Bio’s best interest, and strengthen their bargaining position, to have manufacturing readiness established around the same time”.
I think this makes the most sense. They did express clearly they are going after UK approvals first. Perhaps they expected Sawston to be ready sooner, but COVID delayed some of the proceedings. So they are utilizing that time to rather work on complete data analysis and publication. The publication and full data analysis certainly would have a huge impact with FDA application and fast track things. Hopefully they will release a series of back-to-back high impact PRs in Q3/Q4. It’s 100% clear the trial didn’t fail. They would have had to disclose results otherwise. LL seems confident in her presentations as well! In my mind, we’re fully de-risked at this stage. Even with a UK and EU approval, we deserve a market cap of around $4-5B. And those 2 agencies are fully on board and are in the bag!
Fingers crossed! ;)
Music to my ears! Likely $27 on Monday.
I will go out on a limb and say we hit $27 mid next week, if not sooner.
Could we go up 30% or so leading to ASM? NWBO had similar move the week of their ASM recently in mid May.
It is likely they are preparing for FDA and/or other regulatory applications? I remember when we applied for FDA clearance of our medical device we ensured all the info on our website was current with the technical specs of our device, marketing messaging, etc….It’s very likely something like this is happening behind the scenes!
My sense is LP is going to drop the news when it’s least expected and there will be a series of back-to-back events in quick succession to create huge buzz amongst the scientific community, media as well as support the share price, and trap the shorts!
Merck investor call presentation at ASCO yesterday.
https://s21.q4cdn.com/488056881/files/doc_presentations/2021/ASCO-Investor-Event-Slides_6.6.21_FINAL.pdf
Slide 12 talks about their interest in expanding in cell therapy and T/NK cell engagers... very interesting!
Did anyone record LL’s presentation today?
Merck has additional $9B available starting today from Organon spin off. Leak???