HEB, Hemispherx Biopharma (AMEX)NEW Message Board

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Biotech / Medical : HEB, Hemispherx Biopharma (AMEX)NEW

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To: Ben Wa who wrote (683)	8/29/1999 3:27:00 PM
From: Scott	Read Replies (1) of 857

I'd appreciate any ideas on when HEB might get U.S. approval for Ampligen. As I understand it, the clinical trial protocol that the company agreed upon with the FDA calls for several hundred patients to each undergo a 24 week baseline measurement and treatment regime. Patients are to be treated in about 12-15 clinical centers around the country. HEB is still seeking several more clinical centers for the trial, and then will have several months to enroll patients for those centers. So it seems that in the best case scenario, patient accrual may be complete by the start of 2000, so the data collection for the trial could be completed no sooner than about midyear 2000. Given the needed time to analyze data and prepare the application, an FDA application seems like it could not be submitted by the company before the start of 2001. Even with fast track approval, they would not get on the market until close to 2 years from now. Anything wrong with this reasoning? Thanks for your thoughts.

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