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Ampligen Chronic Fatigue Syndrome Data May Be Sufficient For FDA Approval

 
• By Brenda Sandburg

FDA is reviewing Hemispherx’s reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.

Hemispherx Biopharma Inc. may not have to do an additional confirmatory Phase III trial to gain FDA approval of its chronic fatigue syndrome drug Ampligen (rintatolimod), the company announced July 11.

According to the company, FDA has agreed to review new analyses of the AMP-516 Phase III trial supporting its NDA....

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