You seem to see FDA cautionary approach as black and white. They naturally wanted to test min effective dosage given its potential wide scale application across the broader US population BUT also with a pre agreed threshold (benchmark) that was based on 2x2 efficacy.
NOEL will NOT be an issue with 2x2 given previous and new studies undertaken. Nevertheless we have to supply all the necessary data for them to green light stage 2 at 2x2.
Whilst it has added significant cost and now time using a two staged approach to P3, it has also ensured we have a very high chance of passing the key end points given the known efficacy of 2x2.
Ann: PAR to present at NWR Healthcare Conference, page-25
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