Does this mean that they have provided the requested update to the FDA?
(SRPT) Provided an update on discussions with the U.S. Food and Drug Administration (FDA) regarding a potential application for accelerated approval of eteplirsen for the treatment of DMD. The FDA requested that Sarepta provide additional information from the existing eteplirsen dataset to inform a decision on the acceptability of this dataset for a New Drug Application (NDA) filing under the Subpart H Accelerated Approval regulatory pathway. This feedback was provided in meeting minutes from an End-of-Phase II meeting with Sarepta and the FDA's Division of Neurology Products that occurred in the first quarter.
Does the last sentence mean that they have provided the requested additional information?