I noted Steven's reference to progressing PTX-100 to market. My...

I noted Steven's reference to progressing PTX-100 to market. My understanding of what Steven is relaying to the market is that a registrational trial for this particular type of therapy has the potential for a much smaller cohort than traditional therapies and huge savings on CAPEX. There is a precedent for smaller trials & a fast track path to market.

Yes, SYC mentioned that PTX was considering a similar-sized trial to that of Folotyn.

Folotyn (pralatrexate injection) was granted accelerated approval by the FDA in 2009 for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). It was the first FDA-approved therapy for this indication.

Folotyn’s approval was based on an international Phase 2 trial of Folotyn that enrolled 115 patients, 109 of whom were evaluable. The primary efficacy endpoint was overall response rate (complete response, complete response unconfirmed and partial response). The key secondary endpoint was duration of response.

The response rate was 27% and the median duration of response was 9.4 months.

The ultimately-pivotal trial took 2.5 years.

https://www.fiercebiotech.com/biote...and-only-fda-approved-therapy-for-relapsed-or

https://clinicaltrials.gov/ct2/show/NCT00364923?term=folotyn&phase=1&draw=2&rank=6