Yup, even if one Phase 3 is required, it'll probably has no more than 300 patients. An example would be Promius Pharma / Dr. Reddy's DFD-01, a spray to treat psoriasis. It was granted the 505(b)(2) pathway and its P3 trial had 277 patients.

http://promiuspharma.com/dermatology/docs/201...elease.pdf

https://clinicaltrials.gov/ct2/show/NCT01967069

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Incredibly encouraging, isn't it?

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