Business
Written Response received from the FDA
Written Response received from the FDA.
About this update from Immupharma Plc
[{"type":"text","content":"\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n 14 September\n \n \n 2022\n \n \n \n \n \n \n \n \n \n ImmuPharma PLC\n \n \n \n (\"ImmuPharma\" or the \"Company\")\n \n \n \n \n \n \n Written Response received from the FDA\n \n \n \n \n \n \n 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.\n \n \n \n \n \n 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.\n \n \n \n \n \n The Company is currently reviewing the written response with Avion and will make a further notification in due course.\n \n \n \n \n \n \n \n \n \n \n \n \n This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.\n \n \n \n Ends\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n For further information please contact:\n \n \n \n \n \n \n \n \n \n \n ImmuPharma PLC (\n \n \n \n www.immupharma.com\n \n \n \n )\n \n \n \n Tim McCarthy, Chief Executive Officer\n \n \n \n \n +44 (0) 207 206 2650\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Lisa Baderoon, Head of Investor Relations\n \n \n \n \n + 44 (0) 7721 413496\n \n \n \n \n \n \n \n \n \n \n \n \n \n SPARK Advisory Partners Limited (NOMAD)\n \n \n \n Neil Baldwin\n \n \n \n \n \n \n \n \n Stanford Capital Partners (Joint Broker)\n \n \n \n Patrick Claridge, John Howes, Bob Pountney\n \n \n \n \n \n \n SI Capital (Joint Broker)\n \n \n \n Nick Emerson\n \n \n \n \n \n \n \n +44 (0)\n 203 36\n \n 8 3550\n \n \n \n \n \n \n \n \n \n +44 (0) 20 3650 3650\n \n \n \n \n \...