AquaBounty (AQB)

[DewDiligence]

FDA approves US-production facility for AquAdvantage salmon:

https://www.sec.gov/Archives/edgar/data/1603978/000160397818000041/exhibit991-20180427.htm

The FDA previously approved AquaBounty’s New Animal Drug Application (NADA) on November 19, 2015, for the production, sale, and consumption of AquAdvantage Salmon in the United States. That approval specified that all production facilities for the product would require separate site-specific approvals.

To conform with this requirement, the Company submitted a supplementary NADA to the FDA requesting approval to grow AquAdvantage Salmon at its farm site near Albany, Indiana. The Indiana facility as currently configured has a production capacity of 1200 tons per year and was designed to allow significant expansion. The site has a staff of ten employees that is expected to grow to 25 employees once the first phase of salmon production begins. With the facility now approved, commercial production of AquAdvantage Salmon awaits only official labeling guidelines by the FDA.

AQB also needs FDA permission to import the salmon eggs from Canada as feedstock for the Indiana plant.