Agree Dalts re the significance of the FDA decision to grant an even broader ODD for PTX100 to include all TCL indications. I got the impression from SYC's last couple of webinars that the (good) problem of having both PTCL and CTCL patients in our trials doing so well was causing our team some anguish. Lo and behold, we now have ODD for all TCL cancers.
What has to be considered interesting is that PTCL and CTCL are the main subsets of TCL which gives us, not only, the leeway for a mixed-label registrational trial (if successful) for both PTCL and CTCL but any other TCL cancer types that we haven't yet investigated with PTX100. Could that add another string to our bow?
According to The Leukemia & Lymphoma Society's website (
https://www.lls.org/article/t-cell-lymphomas-tcl
,
"The various subtypes have distinct pathophysiology and molecular profiles. Beyond this, there is geographic diversity. For example PTCLs are rare in the United States and are more common in Asia, Africa and the Caribbean."
I wonder what this could mean moving forward for PTX in terms of next trial design and the market in Asia (should we be successful in getting a drug to market)...?
Also, fingers crossed for ODD in Europe, where exclusivity is even longer than in the US... 10 years!
It's interesting too that in reference to the likelihood of PTX pursuing combination trials, SYC mentioned lung cancer as an example (down the track). Would that be conceivably be due to the fact that both Merck and BMS withdrew their PD1-blockers from the market in SMCL due to their confirmatory trials not living up to their Accelarated Approval registrational trial storyline? If so, then AA for us with PTX-100 could be pivotal for us in so many ways given how PTX-100 is a KRAS marvel with 100% safety!
What are posters' thoughts on this?
