upcoming Covid 19 drug reviews....FDA, Nov 9...Adcom review..
later... UK, Australia
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin marketing authorization application will receive expedited review.
On July 27, 2022, The European Medicines Agency’s Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.
On August 22, 2022, Australia’s Therapeutic Goods Administration (TGA) determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.
FDA has informed the Company that FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet on November 09, 2022, to discuss the Company’s sabizabulin for COVID-19 request for emergency use authorization. |
