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Hemispherx Vows To Fight FDA’s Second Rejection Of Ampligen

 
• By Sue Sutter

In a “complete response” letter, FDA requested at least one new clinical trial, along with nonclinical studies and numerous data analyses, before approval of the chronic fatigue syndrome drug. Hemispherx continues to assert the existing data support approval and plans an appeal to FDA’s Office of New Drugs.

Hemispherx Biopharma Inc.’s vow to appeal a second FDA “complete response” letter for Ampligen (rintatolimod) suggests the investigational chronic fatigue drug will remain in developmental limbo for the foreseeable future.

In a Feb. 4 press release announcing receipt of the action letter, Hemispherx showed no willingness to accede to FDA’s...

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