Sep. 13 at 1:55 AM
$ASBP FDA website specifies within 60 days: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track?utm
FDA has granted approvals <60days in the past for cases that clear-cut meet safety, efficacy and urgent unmet med. need criteria. So 60days is the most conservative estimate if ASBP does rec the grant.
We are in the gd hands of the v well-connected Nancy Taylor.
In a nutshell, fast-track approval announcment cld drop any day between now and Nov2025.
It will be explosive and life-changing for those of us who hv held on against all odds. Millions or nothing. Nfa
