Wednesday, January 10, 2018 12:36:56 PM
This article I found talks about how the FDA responded with positive feedback to the company in the article. Also the article says the company was told by the FDA that 505B2 was an appropriate path to take. So I guess it wasn’t technically granted in the meeting but it sure as hell was alluded to with those words.
So I guess there is a chance for 505B2 to be green lighted... gonna be an exciting day to say the least!
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