expanded access to give patients much needed help and to build up the customer base
Smart and good to establish and warm up the customer base through Expanded Access. No Accelerated Approval and P4 making full commercialisation muddied. Much better to wait for slam dunk approval once EXCELLENCE data is in hopefully with conviction confirming that we have a commercial drug.
Missling may also have determined that he can get Rett approval, even with the EXCELLENCE delay, in time to support the AD NDA as a repurposed drug that needs just one successful Phase 3 trial.