Confidentiality claims are often made by attorneys as a matter of course when material is submitted to government agencies. It’s all boiler plate stuff the attorneys have on their hard drives. There’s no down-side to their being wrong about such a claim–a challenge just leads to their having to do more legal maneuvering (spending more time, billing more hours).
The agency is evaluating the fish as if it were a new veterinary drug, which means the FDA’s deliberations are behind closed doors and that AquaBounty can claim much of the research and other supporting data it supplies to the FDA is confidential.
Yes, they can claim confidentiality. As I said, they often do as a matter of course. Who’s up to reading the statutes and mounting a challenge here? It seems important someone do that. The public has a right to know what’s going on here, to have input into the process of approving these things.