Don't forget, if SAP makes it unapprovable, why did they already approve the same SAP for PIP? 1) The PIP trials are early stage so establishing solid proof of efficacy is not required. 2) The biggest issue with the P3 SAP is the endpoints were changed after they knew the designed trial had failed. 3) The next biggest problem was lack of patient level data and a matched population with the ECA. That can be fixed if worked in advance.
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