GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Priority Review can be granted—and often is granted—without Fast Track; hence I don’t agree that Fast Track per se is highly consequential.

>Additionally, receiving fast-track designation gets the company to have a lot more collaboration and meetings with the FDA about ATryn…<

This is an advantage when a drug program is still in its early stages. In the case of ATryn, however, the important feedback from the FDA was obtained when the company and the FDA agreed on the design of the phase-3 trial.