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Biotech / Medical : HEB, Hemispherx Biopharma (AMEX)NEW -- Ignore unavailable to you. Want to Upgrade?

To: The Street who wrote (513)	10/27/1998 9:34:00 AM
From: waldo	Respond to of 857

Tuesday October 27, 8:44 am Eastern Time Company Press Release SOURCE: Hemispherx Biopharma Hemispherx: Asensio Misstates FDA Position NEW YORK, Oct. 27 /PRNewswire/ -- Hemispherx Biopharma (Amex: HEB - news) said a press release issued by Asensio & Co. today misstates the content of a Food and Drug Administration (FDA) letter to Hemispherx. For clarity, Hemispherx is making the full text of the FDA letter available on its web site at hemispherx.com. Asensio & Co., a financial firm, has in the past several weeks disseminated medical opinions on the efficacy and safety of Ampligen(R). Asensio & Co.'s medical opinions are not based on any information released by the FDA or any other government body, and in fact, contradict the results of clinical trials as reported in peer review medical journals and at scientific conferences. Asensio & Co. distributed this misinformation directly to Ampligen patients, clinical investigators and patient advocacy groups as well as broadly over financial newswires and the Internet. Hemispherx said that this misinformation created an immediate obligation to protect patient welfare, provide full disclosure to clinical investigators and to meet its regulatory obligation to correct material misinformation disseminated to investors. To this end, Hemispherx disclosed a summary of updated data from ongoing clinical trials through a teleconference and other media. The release of this information occurred about two weeks ahead of the scheduled presentation of the detailed findings at a medical conference. The company's corrective program also included issuing a series of press releases and posting information on its web site. The concern expressed in the FDA's letter is that these and other communications were in a ''promotional context'' not allowed under FDA regulations. The presentation of detailed clinical data is permitted and is not considered promotional if in the context of a peer review medical conference, such as the Chronic Fatigue Syndrome medical conference in Cambridge, MA, at which Hemispherx presented earlier this month. Under current regulatory practice, however, the presentation of summary data in non-scientific forums can result in an FDA ''Notice of Infraction'' as being promotional. The FDA confirmed its ''Notice of Infraction'' regarding promotional communications to Hemispherx on October 22, 1998, following an exchange of communications between the FDA and Hemispherx's regulatory attorneys, Akin Gump and Strauss of Washington, D.C., over the prior week. The company said that it is in the process of complying fully with the requests in the FDA's letter. Hemispherx said that its program of clinical trials and applications for approval in both the U.S. and Europe are proceeding on schedule. Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements. SOURCE: Hemispherx Biopharma ------------------------------------------------------------------------ More Quotes and News:Hemispherx Biopharma, Inc (AMEX:HEB - news)Related News Categories: biotech, medical/pharmaceutical ------------------------------------------------------------------------ biz.yahoo.com