Two points of interest:
1. The mean time for a 505 b pathway approval is approx 18 months. https://www.raps.org/regulatory-focus™/news-articles/2017/3/505(b)(2)-approval-pathway-not-necessarily-shorter-approval-times
2. Two external experts. Who are they? Obviously commercial in-confidence. It suggests that a company is in early stage negotiations to partner.
Ann: FDA meeting provides guidance for TPM/Oxymorphone patch, page-6
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