UnbelievableAfter a year of waiting for the 12 week, 35 person trial to start- they are now calling it an "18 month study" and see delay pushing FDA clearance to 2024.
No wonder people are grabbing multi million option rip cords.
"Spectral management is expecting the first patient enrolled in the DIMI home-use study in the third quarter of this year, with the study completed in about 18 months. McAuley said this is about six months longer than previously expected. The delay effectively pushes potential expansion of the products’s FDA clearance from the second half of 2023 to mid-2024."