Hemispherx CEO Carter Speaks: BioBuzz

PHILADELPHIA (TheStreet) -- Some thoughts on the interview with Hemispherx Biopharma(HEB Quote) CEO Bill Carter that was posted online this morning:

Not a lot of news, particularly concerning the status of the Food and Drug Administration's Ampligen review.

Carter acknowledged unresolved FDA "compliance issues" regarding Ampligen manufacturing at its New Jersey facility and a contract fill-finish plant in Spokane, Wash. Carter said remediation efforts at its New Jersey facility are resolved and that the issues at the fill-finish plant will be completed "in the next several weeks."

Here's a quote from Carter I found interesting:

"Now until all those [manufacturing issues] are completed and filed satisfactorily with the agency ... the agency can withhold a final decision on the commercialization of the product [Ampligen]. But we believe we will have achieved what we all pre-approval inspection by the agency so we would expect any time thereafter to receive final comments from the FDA."

Carter has previously stated that he wasn't aware of any outstanding issues that could be delaying the FDA's response to the Ampligen application. Friday, he admitted that the manufacturing problems might be the holdup.

A question: Is it possible that Carter is totally lying when he says FDA has not informed the company about its Ampligen approval decision?

I admit it's hard to believe anyone could be so brazen, especially with the amount of scrutiny Carter is under. Of course, Biopure executives lied about an FDA approval that wasn't, so I've seen it happen before.

With that said, the more reasonable explanation (but still a guess on my part) is that the FDA informed Carter some time ago that the Ampligen clinical review is on hold or in some sort of regulatory limbo until the drug's manufacturing issues are resolved. Why Carter didn't acknowledge this back in May is a mystery to me.