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Citius: FDA Issues Guidelines To Study IPSC-derived MSCs To Treat COVID-19 Patients

Citius Pharmaceuticals, Inc. (CTXR) said it has received a written response from the FDA with respect to the company's pre-investigational new drug application for induced mesenchymal stem cells to treat and reduce the severity of acute respiratory distress syndrome in patients with COVID-19. The FDA acknowledged that the company could apply for fast track designation. The FDA also provided specific guidelines to study iPSC-derived MSCs.

Citius Pharma plans to follow up with the FDA with an Investigational New Drug application under the Coronavirus Treatment Acceleration Program.

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