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Cybernet Data Systems Inc.

Trxade Group Withdraws Emergency Use Authorization for COVID-19 Testing Kit

Strategic Insights

— 2 min read

Trxade Group, Inc. has withdrawn its Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for its partner's manufacture of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit. The decision follows FDA guidance, which states that only one EUA application is allowed per manufactured kit product. The company's subsidiary, Integra Pharma Solutions, initially filed the EUA in an effort to expedite the review and approval process, but now believes it makes more sense for the manufacturer to submit its own EUA application directly.

Key Takeaways:

  • Trxade Group has withdrawn its EUA application for the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit due to FDA guidance that only one EUA application is allowed per manufactured kit product.
  • The company's subsidiary, Integra Pharma Solutions, initially filed the EUA in an effort to expedite the review and approval process, but now believes the manufacturer should submit its own EUA application.
  • Integra Pharma Solutions has secured additional manufacturer relationships for test kit products for distribution, ensuring adequate distribution channels to continue supplying healthcare facilities and authorized providers.
  • The company operates across all 50 states with a central mission of making healthcare services affordable and accessible.
  • Trxade Group operates four synergistic operating platforms: Trxade B2B trading platform, Integra Pharma Solutions, Bonum Health, and DelivMeds app.
  • The company has filed forward-looking statements with the Securities and Exchange Commission, including risks and uncertainties that may cause actual results to differ materially from those expressed or implied.
  • Trxade Group's forward-looking statements are subject to the safe harbor provisions under The Private Securities Litigation Reform Act of 1995.

Statistics:

  • Trxade Group holds 11,400 registered pharmacies on its B2B trading platform (Source: Trxade Group press release).
  • The company operates in all 50 states, with a central mission of making healthcare services affordable and accessible (Source: Trxade Group press release).
  • Integra Pharma Solutions has secured additional manufacturer relationships for test kit products for distribution (Source: Trxade Group press release).
  • Trxade Group has filed forward-looking statements with the Securities and Exchange Commission, including risks and uncertainties that may cause actual results to differ materially from those expressed or implied (Source: Trxade Group SEC filings).

Sources:

  • Trxade Group press release: "Trxade Group Withdraws Its Previously Filed FDA Emergency Use Authorization for Rapid COVID-19 Testing Kit in Response To FDA Guidance"
  • Trxade Group SEC filings: Form 10-Ks and Form 10-Qs
  • Trxade Group website: www.trxade.com, www.delivmeds.com, and www.bonumhealth.com

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