Hemispherx Biopharma (HEB) Says Recently Filed Lawsuit is Without Merit

November 16, 2009 8:49 AM EST

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) said the recently filed lawsuit is without merit. The lawsuit is based upon the false claim that "...defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered..." regarding the Ampligen(R) (Poly I : Poly C12U) investigational product. That claim is irrefutably false.

Upon receipt of an NDA, the FDA reviewers conduct a filing review to determine whether the application is sufficiently complete to warrant a substantive review. During that filing review, the agency may identify matters involving the organization of the application, needed clarification or additional information which need to be addressed before the agency will decide to formally file the application and begin its substantive review. As reflected in the letter quoted above, FDA informed the Company of the agency's decision to file the Ampligen NDA on July 7, 2008.

Apart from matters affecting the filing decision, the FDA reviewers may, at any time during the review of an NDA, request additional information or clarification of previously submitted information. Such requests made during the course of the NDA review are, by the FDA policy, not considered a determination by the FDA of the status of the NDA or of the prospects for approval of the NDA during the current review cycle (see "Guidance for Industry, Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act" November, 2001). A determination of whether or not any outstanding matters need to be resolved prior to approval is only made, through established internal agency processes, at the end of the review. That determination is made by responsible supervisory reviewers and officials with delegated agency authority, in light of all of the completed reviews, based in part on a risk-benefit analysis which takes into account the clinical importance of the drug and the condition being treated, the strength of the supporting data, and the significance of any potentially outstanding matters. Only at that time is a determination made whether any remaining matters need to be resolved prior to approval or can be properly addressed through available alternative regulatory options or post-approval requirements or commitments.

This is why the cited Guidance explicitly states that an end-of-review action letter may omit matters raised in interim communications (even if they were not addressed by the sponsor) and may include new matters that were never raised in interim communications.

Although, as previously disclosed, FDA reviewers have made inquiries and requested clarification or additional information in connection with their ongoing review of the Ampligen NDA, the FDA reviewers did not seek additional information from the Company either with respect to extension of the first PDUFA date of February 25, 2009, or the second PDUFA date extension on May 25, 2009, and have not indicated in any way that either such extension was related to the need for submission of additional clarification or data. Moreover, based on numerous published reports and statements by Agency officials, it is the

As stated in its recent earnings release of November 9, 2009, the FDA has not informed the Company as to any outstanding responses required in order to take action on the pending NDA.

Thus, the class action fraud claim is false. The FDA has in writing stated, "We have completed our filing review and have determined that your application is sufficiently complete to permit a substantive review." Further, the FDA has not sought new information from the Company either with respect to extension of its first PDUFA date of February 25, 2009, or with respect to its second PDUFA date extension on May 25, 2009.

[SM]

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