The Great Pharmaust FDA ODD Approval Sweepstake, page-134

From here https://hotcopper.com.au/threads/ann-positive-clinical-data-filed-with-fda-to-support-odd-request.7900689/

PharmAust files positive clinical data with FDA to support
Orphan Drug Designation request
Highlights:
• Clinical data showing monepantel has the potential to delay the progression of MND/ALS and
provide patients with a survival benefit was submitted to the FDA
• Response from the FDA expected within 90 days
• Recent clinical trial failures by leading FDA approved drugs highlights the significant unmet global
need for safe and effective drugs for the treatment of MND/ALS
• PharmAust remains on track to commence a pivotal registration Phase 2/3 Study for MND/ALS in
H1 CY24

MT would have to stay with the official response times.
Personally I'm thinking that the FDA have had most of the results from the stage 1/2 tests for months now and the top line results is just the icing on the cake. With the failure of the other available treatments the need for a new treatment has never been greater, they (the FDA) have nothing to loose and a lot to gain by not dragging out the decision.