First I'd like to state I know nothing about the Israeli drug approval process, and I would like to know if anyone here knows more.
If in fact the Israeli process is far more streamlined than the U.S. process, I would like to suggest the following proposition.
We know that the the psoriasis cream is market ready, so their should be no question of the quality of the material not being proper for a Pivotal Trial. Here is my "What If" scenario.
We know the Phase 1 Trial as specified in Clinical Trials is a double blinded trial, but what if the IRB and Clinicians recommended expansion of the trial to say ten patients each with psoriasis, acne, eczema, etc, still maintaining the double blind concepts, but clearly indicating that safety was clear.
Now let's say the IRB and Clinicians were thrilled with the results they saw for say two of the diseases. What If they suggested expanding those patients from 10 to say 50, or perhaps more.
Is it possible that with truly great results an Israeli Approval could be granted on such evidence. Please note, I initially stated I know nothing about the Israeli process, I'm not saying this is possible, but I believe Israel is far more progressive than the U.S. FDA and I wouldn't be surprised if such an agreement is possible if the company, the IRB, the Clinicians, and the Israeli Authorities were working together and could see the findings unblinded, and the findings were truly outstanding.
This is certainly not the norm, but it's exceptionally rare to run a Phase 1 Trial with market ready material. Normally Phase 1 and even Phase 2 Trials are not run with Pivotal Quality material, market ready is truly one step above that as it's essentially the same level, but available in commercial quantities, which is not normally the case at the initiation of a Pivotal Trial.
I'm not suggesting this is the case, this is purely a "What If" question.
Gary
