To: The Street who wrote (748 ) 9/19/1998 1:37:00 PM From: Cavalry Read Replies (2) | Respond to of 1637
THE STREET YOU ARE THE MAN/ASENIO BLEW IT HERE, PHASE 3 APPROVAL, $$$ Asensio yesterday defended his criticism of Hemispherx and dismissed its allegation that short-sellers were manipulating the stock price, although he refused to confirm Business Week's statement that he is among those shorting the stock. AMPLIGEN PHASE 3 MEANS IT LOOKS GOOD TO FDA, THEY DONT LET PEOPLE TEST WACKY CURES ON HUMANS, "DRUG IS REASONABLY SAFE AT THE DOSAGES BEING STUDIED" "Technically, it's not approved," she said, even when a drug has been authorized for phase-three human testing, as has Ampligen. But she said the agency does not authorize drug developers to begin such testing without evidence that the drug is reasonably safe at the dosages being studied. IF THEY HAD A PROBLEM THERE WOULD BE A CLINICAL HOLD "If we had a problem with it, what we do is place it on clinical hold until they address the questions or concerns," Cruzan said. THE FDA HATES MAKING CONCESSIONS The FDA has already made concessions in Ampligen's testing. SUFFERERS OF CFS BEGGED FDA FOR HELP, COSTS 15K PER YEAR PER PATINET Last year, after sufferers of chronic fatigue syndrome pressed to receive the drug on an experimental basis, the agency agreed to allow Hemispherx to charge enough to recover its costs. Otherwise, Hemispherx said, it could not afford to provide them the drug, which is made of living material and costs about $15,000 per year, per patient. Under the agreement, only patients with the most severe cases of chronic fatigue syndrome are eligible. An FDA official said then that while the drug's usefulness remained unproven, "we have an open mind." 500,000 SUFFERS TIMES $15,000 MOVE OVER VIAGRA Although chronic fatigue syndrome has itself been controversial, and sometimes dismissed as "yuppie flu," the Centers for Disease Control and Prevention estimates that as many as 500,000 Americans have a CFS-like condition, which it describes as a debilitating disorder in which patients experience profound fatigue after even the slightest physical exertion. GREAT FIND STREET CAV