Replies to post #205388 on Biotech Values

[DewDiligence]

Keytruda monotherapy has 6/14/17 PDUFA in separate sBLAs for first- and second-line bladder cancer:

https://finance.yahoo.com/news/fda-accepts-two-sblas-merck-114500611.html

The first-line sBLA is for patients ineligible for platinum chemo and is based on the single-arm KEYNOTE-052 study. The second-line sBLA is based on the KEYNOTE-045 syudy, which compared Keytruda monotherapy to “investigator’s choice” chemo.