if asenio doesnt come out hard on monday re letter of infraction we all will know he has covered and moved on leaving his followers to crash and burn...window of opp for asassinio, orphan status fiasco was his last pr and his greatest blunder to date...except for messing with doc carter that was catastrophic error.
Hemispherx Complying with FDA Request
PR Newswire - October 23, 1998 18:14
NEW YORK, Oct. 23 /PRNewswire/ -- Hemispherx Biopharma (Amex: HEB) said today that on October 22, 1998, it was one of three pharmaceutical companies receiving a "Notice of Infraction" from the Food and Drug Administration (FDA). The other companies were Pfizer and Bristol Myers.
Hemispherx said that it is fully complying with the FDA request not to undertake any communications about investigational new drugs in a "promotional context." The context of the company's recent communications had been to correct misinformation disseminated in the past few weeks by stock market short sellers. This misinformation included statements about the potential efficacy and safety of Ampligen in the treatment of Chronic Fatigue Syndrome, which could have been of concern to patients currently undergoing treatment under clinical protocols, their physicians, patient advocacy groups and investors.
The misinformation spread by the short sellers was not based on any information released by the FDA or any other government body and contradicted the results of clinical trials as reported in peer review medical journals and at scientific conferences.
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
/CONTACT: William A. Carter, M.D., CEO and Chairman of Hemispherx
Biopharma, 215-988-0080; or Media: William J. Jenks, 212-232-2222,
Fax: 212-232-3232 or Investor Relations: Sharon Will, 212-572-0762
or Fax: 212-572-0764, both for Hemispherx/
/Web site: hemispherx.com
(HEB)
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