Ann: Phosphagenics Pain Program Update , page-80

Thanks Jevelant for your very good post in response to mine. Surprised it hasn’t led to more discussion or debate.

Theres certainly an advantage to knowing some history and the thinking behind the company over my arm chair theorizing.

Fwiw I think your pretty well on the money with your idea that the goal posts have moved. However an unpalatable idea this is it seems to fit with the picture.

I must admit to not understanding how the accelerated approval idea was feasible to begin with.

This is because I don’t understand how you make a clinical bridge between oxycodone (orally) for say shingles using systemic action for pain relief to an argument for pain relief through the skin with no systemic action – essentially just trying to numb the skin.

To go back to a statement you made earlier in this thread:

“I have been told that all that would be necessary is to demonstrate serum concentration in the therapeutic range, and I believe that this message was also contained in various ASX releases.”

So if I understand your argument it is that essentially POH has been using the term “P3” in a way that is highly specific (and quite unusual) to this accelerated approval pathway.

In effect the POH P3 trial was to be a confirmatory PK trial. Simply prove that serum levels are in the skin at the right levels across the right times with a reasonably large sample and your approved.

The problem is how do you know what serum concentration of oxycodone is required in the skin to be of therapeutic value. No-one knows and so P2 and P3 efficacy trials were always going to be required.

Cant see how it could have been otherwise - but obviously someone did a couple of years ago. Its a pretty costly mistake if this has happened.