PTX Media related, page-1087

Thanks Cashie. The fact that Steve is not prepared to share any speculation as to why he thinks the FDA granted us the broader Orphan Drug Designation for all T-cell Lyymphomas is interesting. Is the FDA keen to see PTX100 investigated across a wider range of TCL indications perhaps? Is the fact that PTX100 is exhibiting solid efficacy and safety in both main subtypes of TCL presenting it as a targeted therapy worthy of combination with other drugs down the track or as a monetherapy in some other TCL type PTX100 has yet to study in the clinic?

I originally considered it was due to PTCL and CTCL being the main two subtypes of TCL, so the broader ODD simply covers the two we are pursuing. However, I wonder whether the complex scientific data we don't get to see is more telling about the mechanism of action beyond just our PTCL and CTCL patients (and their ORR and PFS numbers). Bit of wishful thinking here but the broader designation certainly sounds uncommon, highly positive and provides PTX with broader flexibility to investigate other TCL indications within a mixed-label trial.

The fact that the FDA granted it surely bodes well for our PTX100 moving forward towards accelerated approval and a registration trial next.