From the March newsletter: The proposed Phase 2 clinical trial,...

From the March newsletter:

The proposed Phase 2 clinical trial, and other supplementary clinical trial(s), will be used to further characterise the dose response and delivery profile of the TPM®/Oxymorphone patch. All future studies will be designed to increase the commercial value of the patch and de-risk the product.

NOTE: "dose response and delivery profile", i.e. for oxymorphone no placebo effect, small set of subjects and rapid turnaround. Cheaper and quicker. Upon further consideration of the AGM materials it appears that there is no longer any plan to conduct further oxymorphone trials other than those referred to as studies that would be required for FDA registration (an IND). Further Phase II or Phase III appear to be contingent on a partnership deal. (slides 15 and 16)

For our TPM®/Oxycodone patch, we intend to test the efficacy of the product on a number of different localised pain models. The single dose clinical results announced in July 2013 indicate that the delivery profile of the product is well suited for localised pain, whether peripheral or neuropathic. The Phase 2 clinical trial(s) are intended to demonstrate efficacy and assist in the selection of a target indication.

NOTE: "efficacy of the product", i.e. for oxycodone testing for actual pain mitigation, with placebo effect, larger set of subjects and longer time to account for placebo.