Theralase Technologies Inc. V.TLT

Total Time to Accelerated Approval (Months)

[ScienceFirst]

Found this Dec. 01, 2022 updated FDA page 

Accelerated Approvals (

Content current as of: 

12/01/2022 )

that links to this below, where we can see how long it can take to obtain an FDA Accelerated Approval decision.  Columns 5-6-7 are indicative of.

https://www.fda.gov/media/151146/download



More info. here too:

Cancer Accelerated Approvals

• Ongoing

[ScienceFirst]

First time I see this.  For BCG-Unresponsive, Merck obtained the Accelerated Approval. In 0.5 month! BLA 125514 Supplement 79 4 KEYTRUDA PEMBROLIZUMAB MERCK SHARP & DOHME 4/14/2020 4/28/2020 0.5 PROVIDES FOR AN ALTERNATE DOSE/SCHEDULE OF 400MG EVERY 6 WEEKS FOR ADULT PATIENTS WITH BCG-UNRESPONSIVE, HIGH RISK, NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) WITH CARCINOMA IN-SITU (CIS) WITH