2023 The Final Countdown, page-486

I share your enthusiasm but you should know CBER has more on their plate before Remestemcel. The article you are referencing didn't list every BLA in front of them. After wading through the following list, I count 7 decisions ahead of ours...

https://www.rttnews.com/corpinfo/fdacalendar.aspx


Subcutaneous Efgartigimod (BLA)
06/20/2023
FDA decision on SC efgartigimod for the treatment of generalized myasthenia gravis (gMG) in adults
Pending-

SRP-9001 (BLA)
06/22/2023
FDA decision on SRP-9001 for the Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy
Pending-

Aflibercept 8 mg (BLA)
06/27/2023
FDA decision on Aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy.
Pending-

Valoctocogene Roxaparvovec (Resubmitted BLA)
06/30/2023
FDA decision on Valoctocogene Roxaparvovec for the treatment of severe hemophilia A in adult patients
Pending-

AVT04 (BLA)
2H 2023
FDA decision on AVT04, a proposed biosimilar to Stelara, which is prescribed to treat a variety of inflammatory conditions
Pending-

LEQEMBI (sBLA)
07/06/2023
FDA decision in determining whether to convert accelerated approval of Alzheimer's drug LEQEMBI to a traditional approval
Pending-

I/ONTAK (BLA)
07/28/2023
FDA decision on I/ONTAK for patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)
Pending-