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Haven’t been following the message board over the last few weeks. Just wondering what triggered the upside today?
I don’t think LL will speak about DCVAX-L (or trial results for that matter). It’s a neurosurgery meeting and not neuro oncology! This meeting will be similar in nature to AANS that happened in Philadelphia in late April/early May.
What a coincidence! We plan to stay at the resort next weekend en route to Banff the following week. No wonder the resort prices were crazy when we booked!
Amen! The next round of financing and ASM will reveal a lot about their intentions and how much they care about retail shareholders. Otherwise it’s all a lip service that LP delivers via their fan boys!
“Let me make this perfectly clear — every one of my 15 daily posts and every remaining bruised fiber of my being will be used to campaign against an authorized share increase unless management has demonstrated meaningful progress and a tangible business case prior to the ASM.”
Yup, he is great. Very energetic, charismatic, authoritative, and importantly makes it super easy to comprehend. I agree they should involve him more in scientific speaking events.
It’s clear how influential he is in the UK. MHRA and EU approvals are slam dunk, no question! FDA will approve as well.
Who knows! The narrative has shifted so much that I personally do not trust anyone including Thermo. He shouldn’t be revealing stuff if he is on NDA. Anyway, I take confidence in the data that was revealed at NYAS and the comments made by KOLs, brain tumor charity groups, patient advocacy groups, etc.
We will get RAs including FDA. However, it’s highly unlikely we will have RA+reimbursements sorted from any region this year (including UK) regardless of what anyone says. I have quite a bit of experience in this space.
I have been saying since last year that buyout is the best approach for everyone involved.
I think Jama publishes on Fridays! Just saying!
Agreed. And this experience is shared by other neurosurgeons who have worked with DCVAX-L therapy. We will be approved by all 4 RAs. Just a matter of time. Data speaks for itself!
These bloggers can scream from the rooftop all they want but will have no influence on the eventual outcome. ;) I won’t be surprised if the medical community comes together at ASCO and beyond. They could ban some of these posters from future meetings.
We have support from not only medical & research community but also charities and patient advocacy groups.
This below statement from Dr. Toms is significant. They can bitch all they want! Personally I don’t think we should create negative spin against Novocure in social media and stuff. They are approved for a reason. Although the compliance is challenging and not ideal, patients and their consulting physicians ought to make the final call on what’s the best course of treatment. DCVAX-L certainly has a huge advantage here!
“IDHwt GBMs do not live more than 5 years other than those treated with DCVax or TTF. I have patients 5+ year survival treated on both protocols. I have zero long term survivors in 25 years of practice without. Do the math. The p value is highly significant”.
You can also add Director of Brain Tumor program at Barrow Neurological Institute, Dr. Nader Sanai. He tweeted earlier this week too!
Unbelievable. Now that he has verified his identity hopefully he will not block Dr. Stevens and rather engage in a meaningful conversation/debate! ;)
Unfortunately it won’t happen this year. They have thousands of other things they focus on and we are just a tiny drop in the bucket for them, unfortunately. But that’s not to say we won’t be approved by FDA in 2023. We are pretty much de-risked from a data and regulatory approval point of view in my mind. Only a question of time.
I personally don’t believe we will have UK marketing and reimbursements approved this year either. Perhaps we get MHRA approval this year if we are lucky but that’s as far as I’d go. Again, these things take time so there’s nothing NWBO can do….as long as their applications are submitted in a timely fashion!
Good points!
Agreed.
However, I do expect the paper this week or next. If not, they clearly didn’t follow through on what they promised and said all along over the last 20 months. These next 2 weeks are super critical for management to start rebuilding trust with shareholders.
How cool is this?! Director of Brain Tumor Program at Barrow Neurology (one of the top and highest volume neurosurgery centers in the world!) just tweeted this:
🚨 $NWBO #DCVax results below ... massive effort led by Linda Liau @UCLANsgy Looking forward to data and discussion re: external controls. pic.twitter.com/bCrLnV1vig
— Nader Sanai (@NaderSanai) May 24, 2022
LOL, I saved myself from that quandary! Stopped at MS and then decided to get MBA.
I plan to be in Switzerland to attend a scientific conference in September. Happy to hop over to Germany to celebrate our much deserved victory!
They unfortunately picked the wrong battle and the longer this goes on the more damage they do to themselves. This in turn will ultimately result in much wider attention in the medical and investment community! LL, KA, and LP are the most persistent folks I know of….
Cofer Black may be working behind the scenes to collect more evidence while they let shorts play their games for a bit? All of this adds fuel to the fire! Just a question of when the floodgates open!
Could it mostly be exhibitor info detailing NWBO booth presence and/or their expert theatre presentation?
Let us know how your conversations go this morning!
BB,
Agreed. Furthermore, it would be most credible if this comes from the likes of LL, KA, or other KOLs from the field who attended NYAS (including their steering committee and SAB). I think everyone (including NWBO management) is waiting for the publication to come out before they launch a series of offensive against some of these folks including AF, Midwestern Hedgie, etc for their involvement.
On a related note, I can tell you from my own personal experience that the community will come together as long as the data is solid! And they would want the publication to confirm this. From what we saw at NYAS, this appears to be a slam dunk! This is an unmet clinical need so there is no doubt in my mind that all 4 RAs will approve this.
Agreed. Give them until the end of this month to show us they can execute and defend themselves.
One thing we all ought to agree on is not approve reverse split or any major dilution until they get DCVAX-L approved in 2 or 3 RAs. We have great data and it will be approved but we also need to be patient. These things could take up to an year for approval. I just think about how many times Dr. Paul Mulholland said practice changing and landmark results in that presentation last week….and importantly the closing statement of Dr. Brem. Why would these well know clinicians put their credibility on the line in front of their science and medical colleagues for a small biotech company that hardly anyone knows about?
Those were conservative estimates at approval(s) regardless of whatever and however shorts continue to spin it. My sense is we will continue to have to deal with attacks from shorts even after approvals unless NWBO brings in a very influential & credible investor with ton of cash!
My prediction about the share price was over the next 12-15 months in the most conservative and worst case scenario. That’s still a 4-5 X return from today’s share price. And that is pretty much guaranteed. Which investment opportunity other than NWBO is that attractive in todays market if you take a 15 month window?
For sustained higher valuation, I think we will have to demonstrate the uptick in revenue after approvals and that could take years. Again, all of this could change at/before ASCO, but I am not counting on it at this stage!
I am personally now happy that we are de-risked from the perspective of data and will continue to hold until end of 2023. I have worked with FDA enough over the years (on the neurology medical device side) and particularly their actions over the last 3-5 years to know that they will approve this. So this will be a huge boost to the share price as well. But for now, I will give credit to the shorts with the doubt they have created in the mind of retail investors and therefore I am not counting this in my conservative thesis either.
As long as they don’t dilute much and start another trial we will go back to over $2. If partnership or buyout doesn’t happen in the near term, I’d think they will singularly focus on getting DCVAX-L approved for nGBM and rGBM in UK, EU and Canada and start generating revenue. They can then use the profit to invest in R&D.
Buy when there is blood in the street! Is this their (shorts) last ditch effort because they know what’s coming?
We ought to see something this week. Can’t go on much longer! Thinking of buying more but haven’t pulled the trigger yet. Seeing how low this goes today and perhaps buy tomorrow…
We are de-risked from the data perspective. Worst case is UK, EU and Canada approves. We deserve a much higher market cap based on those 3 RAs. At least $3-4B market cap.
Everyone should write to AACR tonight, particularly those from scientific and medical community.
All of this could turn out to be a blessing in disguise for us if this is followed up right away with appropriate evidence. We will certainly get more visibility, and as folks retract their stories it will add fuel to the fire!
Yup. If they do not produce in the next 2-3 weeks then these things ought to happen:
1) Consider buyout offers or at least spin out DCVAX-L business to big pharma.
&
2) Change of executive management and board members in case of partial sell or partnership.
Science and data alone is unfortunately not going to help us win the ultimate battle here. We will limp through RAs and stuff but we may continue to bleed! They have repeatedly shown they are unable to take swift, decisive actions and execute in a meaningful way. Some things never change!
Why is cofer black on the board?
Very likely share price will continue to get pounded on every news until they take legal action on AF and his buddies….and a barrage of media stories asap, the day the publication is out highlighting LL, UCLA, KA, KCL, and NWBO…..
The other option - buyout, partnership or spin out of DCVAX-L (solid tumor) business to large pharma right away
Thanks for the insight. I agree we are golden from a data perspective. I have first hand experience with how collaborative FDA has been lately and typically is towards small to mid size companies….provided there is rigor and respect for the processes…most importantly, we have excellent safety profile and no way in hell FDA will say no to us!
Also, Dr Brem’s statement towards the end of the Q&A is quite telling and for me personally that was another validation of what we have! I was super excited listening to that closing statement from another KOL!
My only concern at this point is this management may take forever to get the BLA through. And the dilution we may go through between now and then. Let’s see how they handle it and how much they genuinely care about long term shareholders!
Actually the opposite phenomenon has been occurring on the medical device side over the last few years. If you had asked me about 4-6 years ago I’d have agreed to it even from a medical device perspective, but not anymore!
Having said that, I don’t have first hand experience on the pharma side. Although have a ton of hands on experience on the med device side (neurology) as I have been at it for almost 20 years now!
Thanks! Are you still expecting it in AOO or some other high impact journal? Would love to hear your thoughts on which journal is most likely at this point.
Depends on the terms and whether they are open to a change in management and board members. Just wondering if long term shareholders would want to risk enduring more of the same that has transpired over the last 12-15 years? Some patterns never change!
Lets wait until ASCO to see how things unfold to understand what they have accomplished in the last 20 months….and whether we can continue to trust them and some of their messengers on what was reported here during that timeframe….narratives have shifted quite a bit, as we all know!
While we are de-risked from the perspective of ph 3 data, retail shareholders still remain at risk of further dilution given the poor execution history of this management.
Some of the top things on my mind:
1) High impact journal publication.
2) Clinicaltrials website update.
3) BLA progress report and roadmap for all 4 RAs. 20 months would be sufficient for approvals but we don’t even know if any BLA is submitted yet (forget about acceptance and PDUFA date!).
I have seen that first hand how neurologists/neurosurgeons come together on important issues including FDA approvals, reimbursements, etc on the medical device side. As long as the data is good and is coupled with excellent safety…,
More discussions amongst the executive circle (on the medical device side) recently is that FDA is taking an even more relaxed approach towards efficacy data as long as the safety profile is fantastic. And this is how RAs around the world will transition in the coming years. Again, all for the patients so they have the ultimate flexibility to choose what they want!
Dr. Toms is taking him on. Responded a couple of times this morning!
Repeating your lies do not make them truths. In all of your clinical experience Dr. Feuerstein can you point me to all of your long term survivors who got another therapy and lived this long? Just one that was not IDH1 mutant please. I will wait.
— StevenToms11 (@Toms11Steven) May 12, 2022
Time for Elon Musk to take action against these frauds that use his platform to spread lie about a life saving therapy that just announced successful ph 3 results!
Who is going to sue him first and when?
Agreed, there is no doubt in my mind.
Seems like he just responded. We might see the opposite of what happened with Biogen’s Alzheimer’s drug recently, where medical community is going to demand DCVAX-L from FDA in the rare instance they do not approve (not likely though!)