The FDA are not there to try and find ways to make like difficult, hold up progress or block success. They are there to ensure the new medicines do not cause a safety issue (has happened before many times) primarily and that claims of treatment effectiveness are valid.
I would be confident that if you have a genuine drug that they will be supportive, also indicated by orphan drug designation and the like. Problems will only arise if something fails the smell test and results are dodgy.
Trofinetide's safety profile is outstanding. I didn't realise how important this is to a deal until I read hottod's link recently. Safety is a major risk as even if the drug works, if there are concerns on safety then it is likely headed for the bin. Phase2 is a safety trial with desired indications of efficacy. Phase3 is the trial to prove efficacy, recommended dosages etc for progress to market. I can't see any reason why FDA wouldn't support P3 with the current trial results.
I have no concerns on P3 from the FDA.
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