Avid Bioservices Inc (CDMO)

[biopharm]

Back to Basics... 1st ...

http://www.marketwatch.com/story/peregrine-fda-agree-on-brain-cancer-drug-study-2012-12-05?siteid=bigcharts&dist=bigcharts

Peregrine has come to an agreement with the FDA on a Cotara Phase III trial with as many as 300 patients and more importantly... with the recent relaxed FDA rules.... if all is trending positive early in the Phase III the approval can be handed much earlier than expected.

"Cotara has been granted orphan drug status and Fast Track designation by the FDA and orphan drug designation by European regulators. Cotara is a targeted therapy that delivers a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue."

"we are now beginning to plan for this global registration study while continuing partnering discussions."

The Phase III trial is expected to compare two dose levels of Cotara in as many as to 300 patients."