Ann: Phosphagenics Pain Program Update , page-49

I assume trial protocols might have been modified on advice from our consultants or on advice from the FDA. It does seem though that the bar has indeed been raised, but by whom?

Also, if this requirement for actual showing of efficacy against pain carries through to Phase 3, and I can't think of why it would not, Phase 3 trials will require a larger cohort, a longer duration, and heftier cash burn.

Trials would need more participants to reach statistical significance, longer durations to drown the placebo effect, double blind protocols in place, etc.

I think any thought of self-financing Phase 3 have evaporated. A deal will be struck ahead of Phase 3 trials.