”What are the chances that iPPS will be disallowed a P3 trial?...

”What are the chances that iPPS will be disallowed a P3 trial? zero”

Love your chartcraft TC, and also fully agree with this. At some point in the next month or so the market will ask itself “Will PAR fail to put the required additional rigour into the trial protocol to monitor for whatever was detected in the rat?”. The answer is quite obviously “No”, in my opinion. They will undertake their consultations with the required subject matter experts, design and install the slight amendment to the trial protocol, add everything into the IND, and tick the last box the FDA have.

The IND will then be open, we’ll be a Phase III asset, trials will begin, ‘Big Pharma’ meetings will intensify, focus will return to the pain scores from Phase 2b (which were great) as well as the WOMAC scores from the NFL players which were stupendous, and everyone will be all “wish I picked up some more under $2 before the IND opened”.