Well, my understanding is that the normal Phase 3 process is either truncated or replicated in a much smaller and quicker trial. The current PTX-200 trial has been expanded to allow more patients to be recruited to 40 (from its previous much smaller size). That suggests that the regulators are seeing great promise in terms of our drug's safety and efficacy. Whilst it pushes out the completion time for our trials, it gives our data greater assurity and likelihood of progressing to an equivalent Phase 3 registrational trial.
The whole truncated "registational trial" process really needs more definitive guidelines for investors to understand exactly what it means in terms of the clinical trial process moving forward, doesn't it, though? But I'm certainly not the best person to ask... given how many time I have googled "registration trials". But, hazarding a guess, it means a much smaller (and therefore faster) Phase 3... and one that can be entered into directly from a Phase 1 expansion trial such as our "Phase 1 / Phase 2" trial.
Hope that helps... ? In fact, given my explanation has once again brought me full circle back to the question: Is the current PTX-200 a Phase 1 or a Phase 2 trial?.... perhaps we need @hottod to shed some light on the matter, as I don't mind admitting that I'm a bit vague on it. Then, of course, there's the Orphan Drug Designation granted to PTX-200 which also begs the question how it plays out in the development pathway.
PTX Price at posting:
18.0¢ Sentiment: Buy Disclosure: Held
