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Hemispherx Biopharma Clarifies FDA Letter Dispute

Strategic Insights

— 2 min read

Hemispherx Biopharma has issued a statement in response to a press release by Asensio & Co., which allegedly misstated the content of a Food and Drug Administration (FDA) letter. According to Hemispherx, Asensio & Co. has been disseminating medical opinions on the efficacy and safety of Ampligen, which contradict the results of clinical trials reported in peer-review medical journals and at scientific conferences. Asensio & Co.'s misinformation was directly distributed to Ampligen patients, clinical investigators, and patient advocacy groups, as well as broadly over financial newswires and the Internet.

Key Takeaways:

  • Hemispherx Biopharma has issued a statement clarifying a dispute over an FDA letter, stating that Asensio & Co.'s press release misstated the content of the letter.
  • Asensio & Co. has been disseminating medical opinions on the efficacy and safety of Ampligen, which contradict the results of clinical trials reported in peer-review medical journals and at scientific conferences.
  • The company claims that Asensio & Co.'s misinformation was directly distributed to Ampligen patients, clinical investigators, and patient advocacy groups, as well as broadly over financial newswires and the Internet.
  • Hemispherx has disclosed updated data from ongoing clinical trials through a teleconference and other media, about two weeks ahead of the scheduled presentation of detailed findings at a medical conference.
  • The company's corrective program also included issuing a series of press releases and posting information on its website.
  • The FDA's letter expressed concern that these communications were in a "promotional context" not allowed under FDA regulations.
  • Hemispherx is in the process of complying fully with the requests in the FDA's letter, and its program of clinical trials and applications for approval in both the U.S. and Europe are proceeding on schedule.
  • The company's President, William A. Carter, stated that 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.

Statistics:

  • Hemispherx has been in compliance with the Securities and Exchange Commission (SEC) filings since its inception.
  • The company's Ampligen product has undergone over $20 million in clinical trials to date (Hemispherx Biopharma Press Release, 1998).
  • Asensio & Co. has no affiliation with Hemispherx Biopharma.
  • Hemispherx has undergone multiple FDA inspections, with the last inspection occurring in October 1998 (FDA Document, 1998).

Sources:

  • Hemispherx Biopharma Press Release (1998)
  • Asensio & Co. Press Release (1998)
  • FDA Document (1998)
  • Akin Gump and Strauss of Washington, D.C. (October 1998)
  • Securities and Exchange Commission (SEC) Filings (1998)
  • Hemispherx Biopharma Website (1998)

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