Apr. 21 at 3:32 AM
$LRMR
LRMR has so many designations. I missed that they already had EMA designation and UK in the works. These designations give locks on 10 years in UK and 12 in the US but I believe there's patents that provide a longer lock. This really shows there's nothing for those impacted by FA. I'm not sure of the timing but they should also get a PRV that they can transfer/sell to BP for at least
$100M. This can fund a commercial launch, if needed.
Breakthrough Therapy Designation (FDA)
START Pilot Program (FDA)
Accelerated Approval Pathway (FDA Alignment)
Orphan Drug Designation (FDA & EMA)
Rare Pediatric Disease Designation (FDA)
PRIME Designation (EMA)
Fast Track Designation (FDA)
Innovative Licensing and Access Pathway / ILAP (UK - Pending)