My very basic interpretation. When the safety protocols were designed with all of these trials they were unique. They found after these last 2 trials that they were too rigorous and made it harder for trial participants. As there is other drug trial competition in prader willi (unlike the last 2), it could make it harder to get participants in a competitive market. Hence the meeting (Q4?) With the FDA to simplify it and be more competitive. Thats the gist I took from it anyway.
Ann: Phase 2 trial shows significant improvements in Pitt Hopkins, page-112
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