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Biotech / Medical : Micrologix biotech -- Ignore unavailable to you. Want to Upgrade?


To: Larry G. who wrote (607)12/1/1999 10:12:00 AM
From: Sean Janzen  Read Replies (1) | Respond to of 792
 
The TD Security report came out May 14/99 well before MBI received fast track approval. I don't want to increase expectations by saying MBI 226 (CVC indication) will start phase III by the end of Q1/99. The wording of the Sept.29 news release suggests that MBI is doing its phase III preparation at this time and will start Phase III at the conclusion of Phase II.

From MBI's news release Sept. 29/99:

As a result of being granted fast track status, Micrologix has worked closely with the FDA to design a clinical development program for MBI 226 that eliminates the requirement for traditional Phase II efficacy studies. Provided that the drug shows an acceptable safety profile in Phase II, Micrologix will be permitted to proceed directly to pivotal Phase III studies. This streamlined clinical and regulatory program will result in substantial savings in time and money. The Company now anticipates completing Phase II in the first quarter of 2000 and is currently discussing the design of the Phase III clinical trial with the FDA.