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Biotech / Medical : Micrologix biotech
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To: Pete who wrote (715)6/21/2000 5:48:00 PM
From: Sean Janzen  Read Replies (1) of 792
 
Pete,

Have you had a chance to read the FDA article?

II. CRITERIA FOR QUALIFICATION AS A FAST TRACK DRUG
DEVELOPMENT PROGRAM

Section 506(a)(1) of the Act states that a drug designated as a fast track product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address unmet medical needs for the condition.

I think the previous paragraph says it all. It is impossible to say for certain that MBI will receive fast track approval on both MBI 594AN and MBI 853NL but I believe both are candidates.

For greater clarification on what constitutes a serious condition I recommend you read the FDA article.

Follow the direction to the article as directed in this posting: Message 13901965

Time will tell.

Sean
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