Hemispherx Cops to Ampligen FDA Delay

Clarification: Feuerstein's use of the phrase "not complete" was meant to describe Hemispherx's New Drug Application as being "not complete for purposes of obtaining a final FDA approval" in 2009. The phrase did not mean that the NDA was not complete for purposes of initial filing with the FDA, which occurred in July 2008.

PHILADELPHIA, Pa. (TheStreet) --Hemispherx Biopharma(HEB) issued an "update" to the regulatory status of its chronic fatigue syndrome drug Ampligen in which the company essentially admits that its prior public statements were false and misleading.

Monday's statement was likely crafted by Hemispherx's lawyers as a way to help CEO Bill Carter wiggle out of public statements he made in May and June claiming the Ampligen application to the U.S. Food and Drug Administration to be complete. Carter insisted regulators weren't asking for any additional information on Ampligen.

Carter's made these statements both before and immediately after the FDA approval decision date for Ampligen on May 25, which came and went without any word from the agency. We now know that Carter's statements were demonstrably false. The FDA application for Ampligen was not complete because several items were outstanding, the company now states. These included FDA requests for data on Ampligen's safety both in humans and animals. The FDA also required additional information about Ampligen's manufacturing.

In its Monday update, Hemispherx said it is still compiling all the data requested by FDA and will not be done until December.

Hemispherx also claims Monday that the company properly disclosed the incomplete nature of the Ampligen FDA application in its filings to the Securities and Exchange Commission during the relevant time period.

What the company's lawyers don't or can't explain, however, is why Carter was telling investors that the Ampligen FDA filing was complete and on track while the company's SEC filings were stating the total opposite.

The discrepancy is particularly relevant because Carter's public statements helped boost Hemispherx's stock price during the spring and early summer months and benefited the company when it went to raise money from investors.