Innovation Pharmaceuticals Inc (IPIX)

[oddone33320]

A P1 safety/bioequivalence trial should be fairly quick as it is in healthy volunteers and the number of patients would be small.

However, for a P2 study, does the primary endpoint HAVE to be PFS (progression free survivial?). Asking because I truly don't know, forgive my ignorance on this. They are trying to prove that Kevetrin is able to safely reactivate P53 in patients (tumors) is my basic understanding. Could that be the primary endpoint after completion of the course of treatment for each patient, rather than waiting to determine PFS?

For Phase 3 the primary endpoint has to be tied to PFS or OS is my understanding as you have to prove benefit to the patient. However, they could find them selves in a position for accelerated approval if all goes well.