Leap Frogging Competition?
With Sesen Bio reeling from the Complete Response Letter (CRL) (issues identified) from the FDA, does Theralase have any real competition right now ? Sesen's Biologics License Application (BLA) for the Companys lead program, Vicineum for the treatment NMIBC was not approved. SESEN may have to do another 100 patient trial, and from what I understand, their 12 month data was about the same as Keytruda, which is to say, not great, and a low bar for TLT to beat if results continue to trend the way they are. Once Theralase gets Breakthrough Designation, the competition is in trouble, even further, IMHO.