Is it possible to jump to a Phase 2 Is it possible we might be petitioning Health Canada and FDA to jump to a Phase 2 with the results we have so far in this meeting planned sometime this May.
I know 6 patience is not a large group but the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy have all returned more then positive results.
Why prolong Phase 1 if there is a way to jump straight to Phase 2 to move this forward in the best interests of medicine.
Any thoughts this is possible?
cashascars