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Re: None

Monday, 07/31/2017 4:56:26 PM

Monday, July 31, 2017 4:56:26 PM

Post# of 38634
If you are wondering about Category 3 HAP(human abuse potential) studies see page 29 of the following Collegium document:

https://www.fda.gov/downloads/AdvisoryCommittees/UCM461640.pdf

36 subjects for nasal and 47 subjects for oral.

If this is what needs to be done, it does not seem that major. Yes it was a setback and will cost a little bit. My forecast was 2018 or 2019 for Rexista product launch anyways... the big question is how much will these tests cost? My guess is not that much based on subject count. IMHO in the range of $1M or a few million. But certainly not tens of millions.