target .27, page-23

I too applaud the reasoned discussion now underway, and would like to add my own question.

The release of 24 October contained this statement:

Based on these positive results (referring to the Phase 1 oxymorphone trial), Phosphagenics will proceed to a Phase 2 trial, although its emphasis will now shift. Previously it was envisaged that the Phase 2 trial would need to prove that the product was capable of providing analgesia for patients with chronic pain conditions. As the Phase 1 result emphatically answers that question, the focus of the upcoming Phase 2 will now shift to defining the dosage regimes to be used with the product and enhancing its commercial value, rather than demonstrating therapeutic effect.

My question is, if the emphasis for the Phase 2 trials is not to be refocused away from proving efficacy for any particular indication, what is the rationale for assuming that oxymorphone "will require more difficult studies probably having to demonstrate both efficacy and tamper resistance in a large N..." when reaching Phase 3?

I don't doubt that Phase 3 trials will be required or that they will require larger patient populations, but is there any other sense in which they would be more difficult? There seems to be an expectation in the minds of some that these difficulties will deter big pharma's interest.

In order to reach a conclusion as to whether this might be so, it would be useful to have some sense of what these perceived difficulties might be, given the Phase 1 success, and assuming that Phase 2 results will only confirm and refine the Phase 1 results.

I also think that while considering these questions one ought to consider how much consultation (perhaps via Neura Therapeutik) might have already taken place with big pharma and how much their advice might have influenced the shape of Phase 2 trials going forward.