Biotech Values

[jbog]

Micromet

Yesterday, Micromet during it's analysts day presentation laid out it's plans regarding their proposed pivotal Phase III trial Blinatumomab.

Their first indication will be in MRD-positive adult ALL. They've just finished a small trial showing that they changed 9 out of 10 patients from MRD positive to MRD negative. This is after the patients received treatment and a bone marrow transplant.

The Company has their phase III trial set up with EMEA so far but not the FDA. It is set up as an single-arm study that will seek to enroll approximately 130 adult patients with MRD-positive ALL. Patients will receive up to four 4-week treatment cycles of blinatumomab at a dose of 15 micrograms/m2/day. Key endpoints of the study include molecular complete response (MRD negativity) and relapse-free survival rate. The Company currently anticipates enrolling patients in both the EU and US.

Does anyone think the FDA would accept something like this?


tia