RE:RE:Accelerated Approval ...How sweet could this timing be! Maybe Roche could be interested in teaming up with us now?
By killing NMIBC tumors earlier with our TLD1433 in early-stage and late-stage, they would avoid more metastasic bladder cancer cases over time! They could end up having a much wider pool of revenues!
Roche knew months in advance that they would have to remove their drug from the market because of failure to reporduce the initial efficacy that led them to Accelerated Approval back in 2016. It quite possible that wanted to stay in this bladdre indication, and by doing so, then watched our initial results and approached TLT for informal discussions, possible jv if Breakthrough or Accelerated Approval were acheived, etc .... If so, that could explain couple of things:
- the advancement, by 30 months, of the "commercial revenues (projected)" milestone in the Feb. 7, 2022 corporate presentation
- the investment of Roger and Kristina in May 2022
- the small pp (2.5M$) of Sept. 22 where Roger and Kristina and Dr. Mandel participated in
- the tiny pp (250,000$) of Nov. 18 where Roger, Kristina, Dr. Mandel and Board member participated in
- the granting of stock options on Nov. 21 as p#25 has reached its 450-days
Big pharmas plan years and months ahead. So could be that.
But whether or not it's Roche, it's not that important. What's interesting though is all the chain of events that lead to an increased participation of the management after reaching p#25 @540-days, that then opens the door to FDA designation (Breakthrough Therapy, possibly Accelerated Approval, etc ...).
But it's the "Commercial revenues (projected)" for early 2023 that is the most intriguing. And that can only come from Accelerated Approval. So maybe TLT had guidance on that possibility from its previous conversations with the FDA between August 2021 (Ph. 1b p#5-6 had then reached 3.5y of cancer-free with a single dose) and February 7, 2022 (moment where this "Commercial revenues (projected)" was advanced to early 2023).
With the recent AA examples posted last week, we know that AA is possible. Our Ph. 2 being a pivotal one, and now being 50% into such study, if we're to get such AA, it has to be now. Add to this that, even with 50% (12 out of 25) of our patients having been undertreated, we still have a CR% of 53% and DR% of 28%. We also have much higher CRs that the recent AA examples posted. Way more. So I don't know what more would the FDA wants in a promosing treatment! We currently check all boxes.