My friends told me that no one could understand my tweets as I struggle with word limits. So apologies for the redundancy here. An analysis of recent development.
1) company states and it is actually required if one wants to file in a jurisdiction, that the SAP would be shopped by all 4 RAs and approved before datalock. Time between the anoincement that they are ready to proceed towards loch (11/2018) to lock (10/5/2020) suggests negotiations were required.
2) data lock happened on 10/5/2020
3) shortly after the RAs from UK and EMA post new study design and endpoints on their clinical trial sites indicating they have approved new design
4) US does not because it is the company’s responsibility to update clinical trials site, but they don’t and shorts bash saying they didn’t get US buy in. A few months back, however, Dr. LindaLiau confirms it was submitted and not rejected by FDA. This is how they do things until actual drug approval. Even an SPA is non-binding. So, since companies can’t speak for FDA and not rejecting is not quite the same as approving, NWBO doesn’t update the site.
5) LL presents database and study design with new SAP at Mt. Sinai in May 19, 2021. This demonstrates the company has alll elements to submit the BLA (did they? … 12 months tick tock)
6) late August 2021 company begins a premarket promotion campaign at ABTA, continues with hardly undbranded advertisement in October magazine, and then has the infamous Tote bag at SNO in November. Booths are pulled from these meetings. (Did this start the accelerated BLA acceptance, add 6 months and one 3 months no cause extension and you get end of May, but I like the first option better as it adds more flexibility to timeline plus or minus 2 months, although FDA can issue another extension to buy more time if needed)
7) NYAS presents TLD, but no PR…why is that? Is it part of a short trap as promised with accompanying FBi sting operation? Sure suspicious that great data drops shareprice 70%. On 70+ million shares traded.
8) they speak for the FDA and post new design & first 2 endpoints on clinical trials.gov. What changed? Why are they now comfortable speaking for FDA? Also, price does not climb despite this confirmation & whacking of primary short thesis. (I believe this is proof that FDA returned the “red-lined label after up to 30 days” following NWBO submission of final step “draft label” if they are will to accept FDA changes with minor language tweeks…the deal is done.
9) No PR… see also 7
10) clintrials only has 2 endpoints, why? Well, this is different than EU because the non-binding agreement with FDA previously, switched to binding after the data was agreed upon (and now presented). The third endpoint missed (curious they ordered the least likely endpoint 3rd… probably an FDA requirement to give FDA more flexibility about 4, 5, and 6.
11) This proves that the endpoints were ordered to preserve alpha and keep hurdle at p=0.05. After the analysis now 4, 5, and 6 are post hos but not necessarily excluded from the label. Dealers choice not companies. This also indirectly proves #10.
12) Is this an FBI sting operation? How to catch criminals?
13) APPROVALS are PENDING … who is on first? What is on second? Does is third really mean all four at once? No PR YET!!!
14) ASCO product theater is on opening day of the industry/scientific congress and NWBO gets access to the media room. What is going to be said.
15) Enquiring minds want to know about BLA submissions. I already know
