So when I see Opexa release more of the same Tovaxin data Tuesday from a subset of patients in a failed phase II study and the stock surge 270%, all I can do is scratch my head, throw up my hands and mutter, "WTF?!?!"
Some Tough Questions for Hemispherx CEO
Let's hope that when Hemispherx Biopharma (HEB) CEO William Carter takes to the podium this morning at the Rodman & Renshaw Investor Investment Conference, an investor or two in the audience hounds Carter with questions about Ampligen, the company's long-delayed chronic fatigue syndrome drug.
Ampligen is now 107 days past due. The FDA was supposed to issue its approval decision on May 25. At first, Carter claimed FDA telephoned the company requesting "one or two more weeks" to review Ampligen. That was months ago. More recently, Carter suggested that an FDA decision would come "in the fall."
All the while, Carter blames the FDA for the delay, citing its overworked staff and insisting that regulators have not asked the company for any additional data or information about Ampligen.Does anyone seriously believe that now? Carter is venturing outside his well-protected cocoon Wednesday to make a rare public appearance at an investor conference. He may have to answer actual questions that aren't pre-screened or otherwise posed by Hemispherx's sycophantic boosters. It should be interesting.
Antigenics Vaccine Booster Buzz UnwarrantedAn FDA advisory panel meets today to review Cervarix, a GlaxoSmithKline (GSK) vaccine that protects women and teenage girls from virus that causes cervical cancer.
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