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.
