Written response received from the FDA15th September 2022 - 3:52 pm
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, announces that, further to the Company’s notification of 7 July 2022, its US partner for Lupuzor™ (P140), Avion Pharmaceuticals (“Avion”), has received a written response from the Food and Drug Administration (“FDA”) to the Type C meeting.
The FDA response was detailed and included significant guidance on next steps for the clinical programme. This included advice on the dosing regime. In addition, the FDA also provided further significant guidance on the study protocol that can be amended to improve the regulatory outcome.
The Company is currently reviewing the written response with Avion and will make a further notification in due course.
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