Apr. 30 at 1:52 PM
$RDHL Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher. RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act (extending US market exclusivity to a potential total of 12 years) and EU Orphan Designation (eligibility for 10 years EU market exclusivity) for NTM disease caused by MAC5
The multibillion-dollar CD market is expected to grow from
$13.6 billion in 2024 to over
$19 billion in 2033 in key markets,6 presenting a significant opportunity for new FDA-approved therapies
