Just a thought about the choices OWCP had in the Phase 1 Safety Trial. We don't know precisely when, but at some time around June, the last of the volunteers for the trial should have reached the 60 day evaluation point. At some point the clinicians running the trial seeing no real safety problem must have recommended to the company that the trial be expanded to take in patients with skin diseases.
The company could have taken the choice of saying no, let's end the trial and let investors, and others know just how safe our cream is. Wouldn't investors get excited about knowing the trial was safe, but of course nothing could have been said about efficacy other than reiterating the preclinical results. Had they said no, they would have no doubt then planned additional Phase 2 Trials, which if we were lucky might be getting started about now, but probably not until next year.
The company choose to do what the clinicians suggested, expand the trial to patients with skin diseases, and really learn the capability of the drug. Certainly this is taking more time, and the trial officially is double blinded, so even if they have a hint, they cannot tell us what's been seen, because they shouldn't have seen it.
I believe the encouragement of the clinicians is all we really should need to know until results are in, and then can be discussed. Unfortunately, the company has really never even told us officially that the trial was being expanded due to the recommendations of the clinicians. Getting information about what's happening is like pulling teeth, it isn't fun, or easy, but in spite of management's silence regarding specifics, I believe their actions are positive. They are preparing products for eventual marketing.
In almost every Phase 1 Trial that's run, a tiny manufacturing capability is developed to make sufficient drug to run the Phase 1 and perhaps the Phase 2 Trial. The requirements for these drugs isn't as great from a quality perspective, and the quantities are only sufficient to meet trial demands. OWCP has taken a totally different approach, they partnered with Amilia who did whatever was required to actually be able to produce commercial quantities of the cream at the higher quality needed to market it, that's what we're using in the trial.
I cannot say whether Amilia already had production facilities that could do this without modification, or if modifications were needed, but regardless they have the capability. Had OWCP needed to build this capability themselves, it would no doubt be very expensive, and probably would have taken years to construct.
We don't know if their, and Mediq's, intent is to get sufficient clinical data to actually gain approval in any country, or if the intent is to have sufficient clinical information, including before and after photo's of people who used the cream, to market it in Germany, and perhaps elsewhere based on the trial which could conclude sometime soon.
Personally I believe the cream will be sold before it's Govt. approved as a drug. However, it will be completely legal to do so in the places where it will be sold, and it will be legal to continue testing it to work toward drug approvals. The tremendous benefit of gaining drug approval is that with them, Insurance companies will pay some of the costs of using the cream reducing the price to the patient that needs it.
Gary
