I noted that some posters are being overly optimistic about the Phase 1 Safety Trial. Please go to the FDA site and correct me if I'm wrong, but as I understand the trial, volunteers for the trial are observed for 60 days totally. In that the trial is being initiated this month, even if it's fully enrolled this month, it will be sometime in June before it can end.
I believe the company has a very high confidence level that the trial will prove the cream very safe, but look at all the things that each patient in the trial must go through. While personally it seems like overkill to me, it is what the FDA insisted on, and the IRB won't violate the FDA guidance.
Even if enrollment extends into May, this trial could be completed in July, as stated on the clinical trials site. To the best of my knowledge the FDA doesn't need to approve safety data from a Phase 1 Trial, but normally on completion of such a trial the sponsor would submit an IND to run a Phase 2 Trial for efficacy. That may still be the company's intent, but I believe they'll also permit Medmar to begin marketing the cream in Green Cross stores.
I don't know precisely what the FDA will ask for in Phase 2, but I'd suspect that it will be no less rigorous than Phase 1, but instead of volunteers being healthy, they'll have psoriasis. Some of the volunteers will get the cannabis based cream, others will get a placebo based cream, and probably after 60 days the patients will be evaluated. I don't know if after the safety trial they'll still insist on so many blood draws, etc. but they very well could.
Personally I believe the trial need not be so rigorous. I think after a week or two any dermatologist could examine the patients and determine if improvement was seen, but by FDA standards, 60 days is short. I wouldn't be surprised if some placebo effect was noted with improvement seen in some patients using it, but the overwhelming evidence should point to the cannabis based cream to be far more effective. For this trial to be registrational, I would think they'd need to have at least 100 patients in the trial.
Gary
