PAR -v- CUV, page-8

MrSnapple, well done for being an investor with CUV, interesting time for you guys! Hey, one clarification, what do you mean by "I hope we have a chance of skipping the phase 3 trails and be approved by the FDA", are you talking about PAR? Do you mean MPS and the chance of a combined Phase 2/3 trial? It wouldnt be possible for PAR to skip a Phase 3 trial totally would it? I cant see that happening as OA for example isnt strictly a direct death causing disease (ruling out indirectly effect of current Opioid treatments etc). The only way I can figure out how we could 'skip' Phase 3 is if the TGA for example allow compassionate use (and perhaps the same equivalent body [FDA] in the US), but in any case we would still need to do a Phase 3 anyway albeit a reduced sample size and hopefully a fast tracked one.

Second question for you/others, what is involved to get European approval, am I correct in saying that CUV have been using their product over there for months now? Is the FDA/TGA equivalent process as rigorous there?