Chronic Fatigue Drug Moving Slowly: Hemispherx's Ampligen Gets "Complete Response"
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA wants more of everything, from clinical trials to resolution of manufacturing issues.
You may also be interested in...
Hemispherx Ampligen Advisory Cmte. Will Be Early Test Of FDA Focus On Chronic Fatigue Syndrome
Ampligen has a shot at becoming the first drug approved for chronic fatigue syndrome, with an advisory panel tentatively slated for Dec. 20. FDA recently unveiled plans to encourage drug development for this condition.
Ampligen Chronic Fatigue Syndrome Data May Be Sufficient For FDA Approval
FDA is reviewing Hemispherx’s reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.
Ampligen Chronic Fatigue Syndrome Data May Be Sufficient For FDA Approval
FDA is reviewing Hemispherx’s reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.