Hemispherx BioPharma (HEB)

[jmbar2]

After reading through the review doc, my impression is that none of the questions are deal-killers. The answer to every concern from the committee is that HEB may need to provide more data.

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(From the Committee's conclusions)

Draft Topics for Discussion

1. Discuss the efficacy data of Ampligen considering the following:
a) Karnofsky performance scale (KPS)
b) Exercise tolerance testing (ETT)
c) Protocol-driven analyses
d) Post-hoc analyses


2. Discuss the safety data for Ampligen.

3. Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?
a) If not, what further data should be obtained?

4. Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?
a) If yes, is the safety profile of Ampligen adequate for approval for the treatment of CFS?
b) If not, what further data should be obtained?

5. Do the efficacy and safety data provide substantial evidence to support approval of Ampligen for the treatment of chronic fatigue syndrome (CFS)?
a) If not, what further data should be obtained?