ImmuPharma Says US Partner Hasn't Had Written Response From FDA Over Lupuzor
August 31 2022 - 3:05AM
Dow Jones News
By Joe Hoppe
ImmuPharma PLC said Wednesday that its U.S. partner for its
Lupuzor lupus treatment hasn't yet received a written response
concerning development and review from the U.S. Food and Drug
Administration, due to general delays.
The London-listed biopharmaceutical company had said on July 7
that partner Avion Pharmaceuticals has received a Type C meeting
confirmation from the FDA. It said then that the statement of
purpose, objectives and proposed agenda of the meeting have already
been agreed on, as has the option to provide written responses,
rather than face-to-face meetings.
A Type C meeting concerns the development and review of certain
products.
The FDA then had agreed to provide a written response by Aug.
29. As of Tuesday, Avion hasn't yet received a written
response.
ImmuPharma said it was in close contract with Avion and has been
advised that the FDA is experiencing general delays in meeting
response dates, and that this isn't specific to Avion or the
meeting for Lupuzor.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
August 31, 2022 02:50 ET (06:50 GMT)
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