FDA grants fast-track status...
What do you know - two pieces of good news lately.
Bear in mind that "fast" here is a relative term. Approval is years
and many many dollars away.
e-coli vaccine approval is the next big milestone.
Good luck to all.
QA
Bioniche wins fast-track status for cancer drug
04/05/06
TORONTO (Reuters) - Bioniche Life Sciences said on Thursday the U.S. Food and Drug Administration has granted it fast track designation for its Urocidin bladder cancer treatment.
Bioniche, which announced in February that the FDA approved its Phase 3 clinical trial with Urocidin, said the fast track designation means that when data from its Phase III program becomes available, it could expect an expedited review of a licensing application for Urocidin.
"This designation gives us great confidence that Urocidin will be available to uro-oncologists for their refractory patients at the earliest possible opportunity," Bioniche Chief Executive Graeme McRae said in a release.
Bioniche said patient enrollment for its Phase 3 program is expected to start by mid-2006.