The Food and Drug Administration is seriously considering whether to approve the first genetically engineered animal that people would eat — salmon that can grow at twice the normal rate.
The official press release from AquaBounty Technologies is below.
15 June 2010
AquaBounty Technologies, Inc.
(“AquaBounty” or the “Company”)
Update on FDA Approval for AquAdvantage® Salmon
AquaBounty Technologies, Inc. (AIM: ABTX), a biotechnology company focused on enhancing productivity in the aquaculture market, announces progress on their pending New Animal Drug Application (“NADA”) for AquAdvantage® Salmon (“AAS”) from the U.S. Food and Drug Administration.
The Company confirms that it has received two further letters from the Center for Veterinary Medicine (“CVM”) advising that they have completed their review on sections four and five of the seven sections of the application. These two recent letters indicate acceptance of the AAS data supporting the durability of its genotype and phenotype, showing that the product is stable and unchanged over multiple generations.
The Company believes that the reviews for the remaining two parts of the application are very nearly complete. As reported previously, all technical submissions necessary for the review and approval of the product have been made and acknowledged. Management has worked constructively with CVM’s reviewers to answer all questions and is confident of a successful outcome in the near future.
Following formal acceptance of the remaining two technical sections, it is expected that CVM will announce the holding of a Veterinary Medical Advisory Committee meeting on AAS as the next step in their formal process for approval of the product.
For further information, please contact:
+1 781 899 7755
Chief Financial Officer
Nomura Code Securities
+44 (0)20 7776 1200
Richard Potts, Giles Balleny
+44 (0)20 7977 0020
Harry Chathli, Neil Thapar, Claire Norbury