I'd say they would have to, Marc. It would be a material event, I'd say. This is a from a contract (written by another company, not the SEC):

1.68. “Significant Development Event” means any of the following material Development events: (a) any material interaction and/or written correspondence between a Party or any of its Affiliates and any Regulatory Authority with respect to the Product; or (b) any material event or result with respect to any Clinical Trial involving the Product.