Perhaps that is why SYC is keen to 1). Pursue a "mixed" TCL trial (ie in PTCL and CTCL) and 2). Start the CMC work now in anticipation of accelerated approval.
Whilst he states that clinicians always favour efficacy over safety, perhaps the inference here is that the FDA regulators favour both. And, that is where PTX100 is really shining. The efficacy is clearly impressing Prof Miles Prince and the safety profile speaks for itself and hopefully gives us an advantage with regards to the new regulations.
I think the "uncertainty expressed by SYC about the accelerated approval pathway for PTX-100" is more due to the fact that we have efficacy results that present similarly for both PTCL and CTCL. He refers to it as a "great problem to have".... however, the fact is that we have ODD for PTCL only... well, that's my understanding. I get the impression that he and the clinicians would like to see both indications studied further.... not just PTCL because it has ODD. And, yeah, two separate trials means up to twice the amount of work and money. SYC is aiming to twist the arms of the regulators I think (well, that's just the impression I get).
PTX Price at posting:
8.9¢ Sentiment: Buy Disclosure: Held
