Hemispherx Biopharma (HEB) Reports a Q3 Loss; Comments on FDA Responses

November 9, 2009 3:08 PM EST

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) reports a Q3 loss of $0.02, 1 cent better than estimates.

On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).

The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.

[SM]

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