RE:RDW speculation. DJDAWG... Good post.
Without COVID-19, our pivotal Ph. 2 trial would have already been completed almost 2y ago. So hard to plan timing for Feb. 2023 as enrollment was anyway out of the control of TLT.
But the investment of the management under different vehicules in:
- May (investing their own money),
- Sept (participating in a small pp),
- Oct. (participating in another pp that was 90% smaller than the original goal) and
- Nov. (grant of stock options)
is though much more telling as they've been planned for FDA Breakthrough Therapy application (p#25 450-days), on incoming convincing clinical data, FDA meetings and, hopefully, potentially off-record discussions with big pharma contacts before February.
By the way, and it guarantees nothing, but Roche is the only big pharma that has a presence in our 3 targeted indications:
- urology (NMIBC)
- pulmonary (NSCLC)
- neurology (GBM)
Note also that, because of non-convincing confirmatory Ph. 3 data, following the initial granting of Accelerated Approval in 2016, Roche officially removed itself 2 weeks ago from the bladder indication that it had pursued. Such exit had become obvious few months ago (before February???) and if they initially decided to enter the bladder cancer market in 2014, it's because it was a market they wanted to make money in, so they would have a second shot with us.
The timing with the addition of our "commercial revenues (projected)" milestone, added in February, and expected for early 2023 can only be based on the granting of Accelerated Approval. Interesting timing, don't you think? And interesting that Roche once received such Accelerated Approval and so, is familiar with such process and is best placed to evaluate the amazing efficacy of our technology. And even more interesting to know that Roche also tried to treat metastasic bladder cancer, something they could be interested in combining with our MIBC (Muscle Invasive) indications.
https://www.fiercepharma.com/marketing/roche-joins-fda-accelerated-approval-revamp-team-removing-a-tecentriq-bladder-cancer-nod