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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: wvalx who wrote (19509)	3/9/1999 10:38:00 PM
From: Little Gorilla	Read Replies (1) \| Respond to of 23519

>>Can anyone also, briefly, run down the 3 phases and usual timelines?<< I have info on how long each Phase generally takes, but it's on my computer at work. In the meantime... FDA REVIEW After extensive toxicological tests and animal studies, a company must decide whether to test a compound in humans. If it decides to proceed, it must first file an Investigational New Drug (IND) application with FDA. This application must include information about preclinical testing and describe the proposed clinical trials. Unless FDA orders a hold for safety or any other reasons, clinical trials may begin 30 days after the application is filed. In addition, an application for clinical trials must be approved by a review board of the institution or institutions where the trials will be conducted. Clinical trials are conducted in three phases. In Phase I, safety studies are carried out on 20 to 100 healthy volunteers. Potential side effects are identified, and a dosage range is determined. Phase II trials are conducted to determine the effectiveness of a drug. Approximately 100 to 300 volunteers who have the targeted disease participate in these trials. Phase III involves 1,000 to 5,000 patients (and sometimes many thousands more) in clinics and hospitals. They are closely monitored to assess a drug's efficacy and safety. If the data generated by these trials demonstrate safety and efficacy, a company submits a New Drug Application (NDA) to FDA containing all the scientific information the company has gathered. NDAs typically have run 100,000 pages or more. FDA has been making progress toward achieving the statutory six-month period for NDA review. The average review time for all NDAs approved in 1997 was 16.2 months, down substantially in the past five years [Figure 3-2].