In the US, designation of a Coordinating Investigator for multicenter trials is not a regulatory requirement. Does the absence of a Coordinating Investigator's signature on the clinical study reports for Phase 1 and Phase 2 trials conducted only in the US under a US IND (by a US Sponsor), jeopardize the acceptance of the eventual MAA under the centralised procedure? For clarification, the plan for US/EU pivotal phase 3 trials, will be to designate a coordinating investigator.