Regulatory Pathway

Bethanamist qualifies to follow the US FDA’s accelerated 505(b)(2) regulatory pathway as shown below.  The Company is already preparing for Phase II clinical trials, while also conducting a 14 day non-clinical toxicity study.

FDA’s 505(b)(2) program is designed to expedite the review process on previously approved drugs or active constituents

The 505(b)(2) program is extremely valuable to pharmaceutical companies with formulations that qualify because there is a lower risk of failure, lower costs and accelerated development due to fewer studies