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.
Annals net yet released…I check every 5 min. Anyone know why?
Exactly XMaster!. Weak handed shorts definitely took fuel out of the rocket ship. Humans are so damn emotional and follow the leader. It is like the OXBOW incident a few skilled hands can manipulate the mobs to lynch an innocent man on their behalf.
I know several of my comrades that dumped quite a lot only to regret it by days end. We monkeys aren’t as smart as we think, the reptilian brain overpowers us almost every time.
JED & H2R, thanks for this! I see your analysis here as proof of FDA’s hand in the final output. If they were just trying to “perpetuate a scam” they would not have shown the adjusted data which undersells the actual observed impact. The reason we are seeing the ‘worst case scenario’ here is that it is the one that has been blessed IMO.
Great work!
I don’t think the market even knows $NWBO just yet. The 15k shareholders and the other side does, but my feeling is the attack on Tuesday was designed for just that to keep other potential cash from entering.
FDA will look at both raw data and adjusted data. I think we saw the data that the regulators have aligned to already.
You just have to ask yourself what was the purpose behind delaying results they had 12 months ago and the answers become clear. It certainly wasn’t to defend stock price or build investor support. Just whose support were they working on?
Every good climax has a foreshadowing event. Yesterday was the foreshadow, not the bombshell.
Does some have a link to the slide set? I would like to study the numbers a little more closely.
Not sure if this has been discussed and apologize if a repeat.
The amazing results yesterday are adjusted during the risk factor analysis. This process alters the true raw results in an effort to equalize risk factors across trials. As well results are compared from time of randomization which somewhat handicapped DCVax since randomization in their trial began 3.1 months after surgery, but a fair proportion of the ECA database population was randomized after 6 weeks.
The impact of this was that the 3 year and 5 year KM estimates are reduced for DCVax. Raw data would show better numbers vs adjusted numbers. IMO the adjustment is proper for comparison but also the real world clinical meaning is in the raw numbers. I would love to see the unadjusted data set.
To each his own. I am just sharing information that happens to support my BLA and reveal/release thesis.
You make your own decisions
Seems FDA issuing extensions may be pretty common practice during this pandemic
Amicus Therapeutics Receives Notification of PDUFA Date Extensions for AT-GAA
https://finance.yahoo.com/news/amicus-therapeutics-receives-notification-pdufa-200100342.html
Thanks, Pharmboy and others! Everyone has their own reasons why they are here. This is my reason…
Don’t let them fool ya…you’ve got a mind of your own
Great post MERV!
FDA approved the SAP, the great, wonderful, compassionate, brilliant and truthful Dr. Linda Liau already told us so.
If you’ve waited as long as I have, and you still have FOMO, why would you sell before or especially after yesterday?
That is your answer.
Great data will be rewarded and this is an investment not a trade to me.
Think about the morale in GBM patients who saw great data and were then deflated by the doubt sellers created.
SHAME
SHAME
Think about the morale for Dr. Linda Liau and UCLA/other investigators when they saw the reaction.
SHAME
SHAME
Think about the morale among long term shareholders when they saw the reaction.
SHAME
SHAME
I think about the likelihood for approvals pending
HAPPY HAPPY JOY JOY
HAPPY HAPPY JOY JOY
HAPPY HAPPY JOY JOY
HAPPY HAPPY JOY JOY
Very curious price action all day yesterday.
SHAME
SHAME
SHAME
SHAME
SHAME
SHAME
SHAME
SHAME
SHAME
SHAME
I certainly hope DOJ was watching very, very closely.
Clearly, the data we saw yesterday makes this drug approvable everywhere!
3 mo gain on mOS in for ndGBM
3x 5year OS in ndGBM
Even better outcome in rGBM
Global manufacturing in place
Miss on a surrogate endpoint PFS which is explainable by MOA and a surrogate for survival (see above)
Maybe the safest drug every studied
A rare disease, universally fatal population in a horrible disease with poor Quality of Life after diagnosis.
NO BRAINER (no pun intended as it would be completely insensitive)
BLAs have already been submitted and will be approved IMO!
Pins and needles
Since they made the presentation available from a link on their website simultaneously with the actual presentation they do not need to release a PR to meet reporting requirements. My guess is they will hold the PR until after hours or the morning of the publication release.
The real qustion is given the results we saw yesterday why not release the data 16-17 months ago, or at least at SNO last year given the fact that they had the data in hand shortly after locking the database on October 5, 2020?
Well, we know that it hit on the two big one the primary OS outcome in ndGBM and secondary rGBM. We also know that they were willing to present the data before publishing it. LL presenting at SNO would have been as credible as at NYAS with the most targeted provider audience for your product and more press than NYAS produced. Hee are a few ideas:
- NYAS was in the big boys back yard, both pharma and Wallstreet
- LP and LG had said they would have several rapid fire press releases in a short window of time to counter the expect sell attack that we saw yesterday
- Annals of Oncology publishes their June edition tomorrow which os 10 days delayed and thus conveniently right after NYAS.
- May is Brain Cancer awareness month
- we would be foolish to believe the publication can counter the attack that was initiated by the presentation so there must be more to the plan than that.
- I have previously reported my logic for why I think approvals are pending. Now, we know that the missed PFS endpoint that was expected by most likely prevented a priori analysis of the other endpoints, but that does not mean they were not performed, can’t be published, or weren’t considered by the regulators.
- I believe the ‘mixed’ result would lead them to want to ensure approval before releasing the new SAP analysis for fear of many things. If they were looking for just appeasing shareholders and Wallstreet, why wait so darn long?
- They need cash, but yesterday’s action doesn’t make the pricing of an offer very favorable. Given how shrewd LP has been regarding capital creation, I think it is obvious that she has another plan and multiple alternatives.
My conclusion, the June 4th ASCO presentation will discuss bigger news that the great data that we saw yesterday. Either buy-out/partnership, approvals. or both.
Pins and needles folks, pins and needles
Major… anything less than $4 by days end is just plain ridiculous.
I guess being on OTC with a cabal of price containers has its impact, but a company about to release a positive study that will be the instant new SOC when approved later this month. $4 is what the minimum should be before the first of those two gets revealed.
Why are people still worried? This has been the biggest foreshadow of an outcome in the history of the industry.
They twice published the blinded data, they then compared it to contemporaneous control data base, they got the approved new study design in EMA/UK they got their EU plus manufacturing facility approved, they are on the verge of get automated massive expansion approved, LL told us FDA accepted the SAP, and LL showed us that in the next round of research for ndGMB and rGBM, everybody gets DCVax, some get combo with the first Poly ICL combo increasing benefit, teasing that the second CI combo also adds benefit, so they then start a third triple combo study.
Are people not familiar with the steps one takes when seeking regulatory approvals?
Again global SAP approval happened BEFORE 10/2/20, EMA/UK posting happened after May 2021. Now what next step would trigger regulators to change Clinicaltrials.EU?
I can tell you what and it means approval is pending!
Partnership deals usually include the BP or BB taking a ten percent stake in the little guy. It is very possible LP did’t like the terms all around when she was perceived as having a weak, clueless hand. The price the BP may have been willing to pay even six months ago may be a small, small fraction of what they will need to pay after ASCO.
Now, with BOMBSHELL results pending, and global approvals coming, it is going to cost a partner or buyer WHOLE LOTTA
MONEY, MONEY, MONEY…..MONEY
MONEY, MONEY, MONEY…..MONEY
MONEY, MONEY, MONEY…..MONEY
Hi NY1972, ARCUS is superior in soooo many ways. Precision Biosciences is the winner in the long term.
I will never get why Wallstreet sometimes buries the best and elevates the rest. Don’t get me wrong the advanced programs of CRSP, INTL and ALLO deserve credit, but the risks are high. Higher than DTIL. That is for ding dong sure.
Hi Senti, I think they get broad approval but are required to study rGBM further. Maybe a phase 4, maybe a large effectiveness database, doubtful a placebo controlled patient killer.
Peace, love and lots and lots of money to you and your daughter.
Happy Mother’s day Senti!
My prediction, rGBM is positive and will be covered under the label, but there will be a post-marketing commitment there. No biggie at all, but a commitment none??the??less.
Happy, will you ever live up to your name?
I can’t stop shaking with excitement and you still have to focus some attention on that fictitious rug.
I guess every silver lining has a touch of grey, at least for you. I only see that shiny metal because grey is a different color.
I didn’t complete my registration as I got sidetracked by my overwhelming workload, and now registration is closed. I will need to rely on IHUBers to keep me posted as news breaks. I was actually looking into getting there live with my delay so that I could meet and congratulate them all firsthand. Now, I can’t even watch virtually.
My bubble has been a little deflated but not burst.
Believe me Horse, I was salivating at $0.70 but have done my best to practice restraint as I have been asked to do by my most important supporter. That support has been here for me and made me very happy much longer than my interest in this company and the amazing women of DCVax.
Love it, Jesster… this giddiness is absolute euphoria but my nervous system can’t manage this much excitement for much longer.
Linda…Drop the Confetti and give your victory speech!
The updated version
In April 2021, 6 months after locking a database and thus 5 months after statistical analysis could have been completed, Linda Liau presents the contemporaneous control database for the first time in Utah. This not only includes the rationale for how to use the database, but also the validation against two failed treatment arms and one successful treatment arm. There is more but that is sufficient.
In May 2021, at Mt Sinai, NYC and just prior during a CME lecture, she adds the overview of the statistical analysis plan (SAP) where the primary will be evaluated by three different methods, where all individually point to positive outcome leads to success. BTW no arrow point to a failure option. The first secondary is also outlined.
This demonstrates that they now had all of the data elements in place to submit a BLA. I personally believe this application has been rolling ever since August 2015, but that is a side bar which is debatable. Obviously manufacturing is part of it too, but Cognate was already certified to produce DCVax for US and Canada. So consider they remain saying that they would still need to apply for accelerated review, and this says that may not matter as were a just about 12 months from this point in time.
Sometime around this time ATLnsider finds and posts proof EMA & UK have accepted the new SAP. Reminder LP said one SAP, all four regulators must be aligned and we now have the proof we need but so many still doubt. This BTW is also proof the process has begun ex-US. Given the April presentation, I assume this indicates acceptance of the BLA, the SAP would have been accepted before she talked about it.
In July, LL tells her colleagues to stop saving tumor tissue in paraffin as that destroys the ability to make DCVax. She tells them instead they need to start cryofreezing the tissue. This is expense, at cost to a patient presently, but none the less one of the most ethical, compassionate people on Earth recommends this out-of-pocket expense. This indicates to me she anticipated approval in the not too distant future.
In August, NWBO starts a premarket promotion campaign taking out a full page advertisement that meets the allowable claim limit… Disease, MOA, Branded trade name. Previously all references to DCVax did not carry a registered trademark symbol which is an essential component here. Side bar, even Fran Houffer updates a six year old PR announcing their partnership with NWBO to include the registered trade mark. Also critical, they do not have a booth at this ABTA meeting as any step beyond the limited premarket promotion allowable is a serious violation. This is still available to view as a less impressive half page advertisement without some pretty inspiring imagery.
In October the ABTA magazine has a barely unbranded advertisement for NWBO and their dendritic cell vaccine which makes some wopping claims. They use the same exact color scheme and font which along with the other info is a bit risky.
In November at SNO, they pull the presentation and exhibit booth and people go ape-$hip but I notice that the tote bag give away has Trademarked Brand name and MOA and call out a coming soon campaign. I get bashed, explain myself, attorneys on the board find the regulation and see that I quoted it almost verbatim not having read it but immediately reading it then and feeling vindicated. Then someone posts the 2018 bag trying to call me a clown, but trick is on them as it bares no registered trademark. It was after that someone private messaged me about the August advertisement…BINGO, no doubt on my end. I have explained my mistake about path 1 vs path 2 and the 6 month time bound nature & will not here.
Premarket promotion requires FDA approval and indicates they plan to approve but ducks are not yet in a row. It rarely happens, but does when they too want a life saving drug or meaningful benefit in patients hands as quick as they can and want to collaborate.
December & January we all know about the UK manufacturing progress, and most understand that it is in and of itself indication that the UK regulatory process is in full swing.
In March, LL confirms FDA accepted the SAP… reminder one SAP, all regulators… i.e, this is old, old news to me. But just like when I called out the last 32 patients were only put on drug due to the randomization imbalance the instant the JTM pub hit, I like to look immediately for confirmation. Back then the other side fought me too, showing their complete ignorance of modern trial conduct or their lack of respect for your intelligence. Similar with LLs confirming statement about FDA, there is no doubt.
LP and LG have always said they are setting a trap for illegal shorting and will have a succession of positive news. Well January took a little longer than planned for the next step but May is not too far away and we are more confident and ready for this battle. I contended all along until just recently when I flip-flopped that LG was not lying when he said PR in close proximity to a conference, followed TLD presentation, then publication. Most longs believe even that is not enough for the other side and their bag of tricks…you need approval or a buy-out/partnership too.
Enter NYAS, Dr. Linda Liau seems to have a certain affinity for the city that has honored her with a prestigious life time achievement award and has broken lots of news/combo news there. That PR again says everything without saying much at the same time, kind of stealthy, huh? And now, Dr. Cloughesy confirms this in a video posted by LET.
Now, if they submitted before the August Campaign began under accelerated review they would have anticipated an answer in February and it looks a little like they were laying those plans, however COVID and other wrinkles. FDA can always issue a 3 month delay, even without cause, and dors so more often than you may realize. So that lines up to May approval. If the standard review is associated with the earlier timing I proposed, that lines up with May approval too.
There was a lot else I am sure others can add, but I am feeling real darn lucky right now.
I later added that I believe Lykiri confirmed that they have had Regulatory Submission consultants on the payroll for a long time. They also have uplist consultants and hired full-time a regulatory expert for Canada named by chance Krysten Powers. That is a whole lot of Powers in one small company.
The small ax is now sharpened to cut the big, big tree down. And a falling tree actually does make a heck of a lot of noise even if the Some types aren’t in the forest to hear it. There will be plenty of attention after ASCO.
In April 2021, 6 months after locking a database and thus 5 months after statistical analysis could have been completed, Linda Liau presents the contemporaneous control database for the first time in Utah. This not only includes the rationale for how to use the database, but also the validation against two failed treatment arms and one successful treatment arm. There is more but that is sufficient.
In May 2021, at Mt Sinai, NYC and just prior during a CME lecture, she adds the overview of the statistical analysis plan (SAP) where the primary will be evaluated by three different methods, where all individually point to positive outcome leads to success. BTW no arrow point to a failure option. The first secondary is also outlined.
This demonstrates that they now had all of the data elements in place to submit a BLA. I personally believe this application has been rolling ever since August 2015, but that is a side bar which is debatable. Obviously manufacturing is part of it too, but Cognate was already certified to produce DCVax for US and Canada. So consider they remain to say that they would still need to apply for accelerated review, and this says that may not matter as were a just about 12 months from this point in time.
Sometime around this time ATLnsider finds and posts proof EMA & UK have accepted the new SAP. Reminder LP said one SAP, all four regulators must be aligned and we now have the proof we need but so many still doubt. This BTW is also proof the process has begun ex-US. Given the April presentation, I assume this indicates acceptance of the BLA, the SAP would have been accepted before she talked about it.
In July, LL tells her colleagues to stop saving tumor tissue in paraffin as that destroys the ability to make DCVax. She tells them instead they need to start cryofreezing the tissue. This is expense, at cost to a patient presently, but none the less one of the most ethical, compassionate people on Earth recommends this out-of-pocket expense. This indicates to me she anticipated approval in the not too distant future.
In August, NWBO starts a premarket promotion campaign taking out a full page advertisement that meets the allowable claim limit… Disease, MOA, Branded trade name. Previously all references to DCVax did not carry a registered trademark symbol which is an essential component here. Side bar, even Fran Houffer updates a six year old PR anouncingntheir partnership with NWBO to include the registered trade mark. Also critical, they do not have a booth at this ABTA meeting as any step beyond the limited premarket promotion allowable is a serious violation. This is still available to view as a less impressive half page advertisement without some pretty inspiring imagery.
In October the ABTA magazine has a barely unbranded advertisement for NWBO and their dendritic cell vaccine which makes some wopping claims.
In November at SNO, they pull the presentation and exhibit booth and people go ape-$hip but I notice that the tote bag give away has Trademarked Brand name and MOA and call out a coming soon campaign. I get bashed, explain myself, attorneys on the board find the regulation and see that I quoted it almost verbatim not having read it but immediately reading it then and feeling vindicated. Then someone posts the 2018 bag trying to call me a clown, but trick is on them as it bares no registered trademark. It was after that someone private messaged me about the August advertisement…BINGO, no doubt on my end. I have explained my mistake about path 1 vs path 2 and the 6 month time bound nature & will not here.
Premarket promotion requires FDA approval and indicates they plan to approve but ducks are not yet in a row. It rarely happens, but does when they too want a life saving drug or meaningful benefit in patients hands as quick as they can and want to collaborate.
December & January we all know about the UK manufacturing progress, and most understand that it is in and of itself indication that the UK regulatory process is in full swing.
In March, LL confirms FDA accepted the SAP… reminder one SAP, all regulators… i.e, this is old, old news to me. But just like when I called out the last 32 patients were only put on drug due to the randomization imbalance the instant the JTM pub hit, I like to look immediately for confirmation. Back then the other side fought me too, showing their complete ignorance of modern trial conduct or their lack of respect for your intelligence. Similar with LLs confirming statement about FDA, there is no doubt.
LP and LG have always said they are setting a trap for illegal shorty and will have a succession of positive news. Well January took a little longer than planned for the next step but May is not too far away and we are more confident and ready for this battle. I contended all along until just recentl when I flopped that LG was not lying when he said PR in close proximity to a conference, followed TLD presentation, then publication. Most longs believe even that is not enough for the other side and their bag of tricks…you need approval or a buy-out/partnership too.
Enter NYAS, Dr. Linda Liau seems to have a certain affinity for the city that has honored her with a prestigious life time achievement award and has broken lots of news/combo news there. That PR again says everything without saying much at the same time, kind of stealthy, huh?
Now, if they submitted before the August Campaign began under accelerated review they would have anticipated an answer in February and it looks a little like they were laying those plans, however COVID and other wrinkles. FDA can always issue a 3 month delay, even without cause, and does so more often than you may realize. So that lines up to May approval. If the standard review is associated with the earlier timing I proposed, that lines up with May approval.
There was a lot else I am sure others can add, but I am feeling real darn lucky right now.
I am truly blushing with all these compliments, thanks everyone. I am also shaking with excitement and can’t sleep. Just doing what Hoffman asked and since he has been carrying the torch that Fizzer dropped and Biosect and DocL never let go of, I figured he deserved a clear and concise answer.
Also just doing what I love to do…cheerleading for the two greatest most empathetic business women I have ever seen and recognizers of scientific truth which I respect deeply. Linda Powers and Linda Liau are my heroes, added to a long list but to highlight my Grandfather and Edwin Moses, the man who could not be beaten, even by disability.
Thank you to PQR for letting me see how important it is to cheerlead because your comrades in arms need it. As I said, garb my hand if you need the confidence or Biosects or Doclogic’s or Senti’s or Lykiri’s or so many others. I too wish RKMatters was here for this ride with us.
When my confidence faultered because it looked like I may never work again much less live a painless, useful life, my best friend Mike and my Dad had the confidence I needed and I am just repaying karma. When I needed it again for personal reasons they still had my back as did Goodtime from this board and several of my BOYZ that read this board but I see weekly.
We get through challenges together. That is how goodness defeats evils. I know I have played this one for you so many times before, but Tuesday Dr. Linda Liau is doing it again in New York City, the city of blinding light and big dreams. Is she just MAGNIFICENT?
PQR, thank you. I accidentally deleted your private message before I could get back you. Sorry about that.
Thanks Sojo. I really appreciate your posts but don’t say so enough. When this is all done, I plan to go back and study them. I will apply your brilliance to my other investments and make a mountain range out of a mountain.
What site to you use for the graphing?
It is telling that they can’t even drum up enough strength anymore for anything more than a blip which will soon be a rounding error
BEWARE STOP LOSSES! That is how they steal your shares in speculative biotechs.
Ok now, if my hand is strong enough for doubters, grab hold of Dr. Tim Cloughesy’s hand instead.
Thanks LET! I always enjoy the confirmation of what I already know
Oh yeah, I think it is Lykiri that can tell you exactly when, but they have had Regulatory Filing consultants on the payroll for a long time now
He or she who still doubts grab hold of my hand… I have enough confidence for the entire world on this stock and May 10th.
Those that bashed me over my premarket promotion claim refuse to accept my adjustment and correction. They will soon learn otherwise.
If you are the big big tree, we are the small axe sharpened to cut you down.
Who so ever diggith the pit, shall fall in it uh huh Aaaand
Who so ever diggeth the pit, shall bury in it yea yea BURY IN IT
Haven’t been on the board much. Is this what you are looking for
Long and Gone, Cleary not, not even the shorts… that PR had Linda Liau’s name in it. Hello? People that have any doubt left just do not understand the ramifications of that seemingly small, actually huge tidbit.
Anyone who has any doubt that DCVac will crush historic controls on OS is absolutely lying to themselves.
Anyone who thinks that FDA did not approve the SAP is absolutely clueless about how FDA operates and speaks.
Anyone who thinks a BLA was not submitted, well I just can’t breakthrough that thick of granite.
Anyone who thinks there is a risk that FDA will not approve this drug just hasn’t looked at what they have approved and why. GBM is the exact definition of HIGHEST of the HIGH UNMET MEDICAL NEED. Exondys 51 had quite literally ZERO efficacy data, and questionable in vitro data, but it was safe and Families and patients watching their kids melt away did not care as it was safe and FDA listened to them. Approved a drug with Absolutely No Proven efficacy.
Some People are either clueless or downright stupid.
Gamestop, brothers and sisters, Gamestop Nuff Said
Who in their right minds is selling this stock with only on trading day to bombshell positive news?
Shocked to look for first time today and see us down.
People must not understand the ramifications of the PR that said everything while saying close to nothing.
Not just the brass, Eric Ramos, Krysten Powers… nough said!
You all show up to the party
Drop the mic
This goes to all the longs who hung in there with me so long.
I actually know one of these guys… he was the gatekeeper security guard for Lurie Children’s Hospital many years after being famous