It sure seems to me that the P2b trial for Prurisol was entremely detailed as to number of patients (considering Otezla P2 only had 30), included a detailed quality of life questionnaire that was included per IPIX request, has film history of skin improvement, primary and secondary objective for both PASI (primary) and IGA (secondary)as to efficacy, secondary endpoint for itching, virgin trial participants as to psoriasis medication history so that improvement could only be due to Prurisol, etc and it leads one to believe that IPIX mgt had more than just a plain P2b trial in mind.
I believe when you combine the above with the 505(b) fast track and the decades of safety info from the primary active ingredient that IPIX mgt was looking at making this something of a P2/P3 trial. FDA already has lots of empirical data that the drug is very safe, the virgin trial patients will show exactly how efficacious Prurisol alone will treat psoriasis, we have lots of feedback on quality of life improvement, so what is left to prove from a P3?
Why not have a broad allowance for doctors to request Prurisol with the stipulation that they have to provide feedback of results. This would allow FDA to see if Prurisol doesn't work when patients had previously taken a different psoriasis treatment, if they all had quality of life improvement as to itching, etc.
Would be right in line with Leo's thinking of cutting costs when possible so he believed taking a larger and more detailed P2b trial would greatly pay off with not needing an overly large or having a long-delayed P3 allowed should a P3 be deemed necessary.
I think the initial P2b top end results PR will also include some data regarding some secondary endpoints which will greatly enhance the efficacy PASI number alone.
Still excited, confident, and sure the science will win out.
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