Allergy Therapeutics PLC
01 November 2007
1 November 2007
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Update on FDA Clinical Hold
Allergy Therapeutics today provides an update on the clinical hold that has been
placed by the United States Food and Drug Administration ('FDA') on the
Company's product development programmes. On 11 July 2007 the Company announced
that activity on its clinical studies had been placed on hold by the FDA whilst
the Agency fully assessed the report of a rare adverse event classified at that
time by the physician involved as 'possibly related' to the study drug.
The Company has now had a 'Type A' meeting with the FDA. Prior to the meeting
Allergy Therapeutics submitted a comprehensive package of information to the
Agency. The meeting was constructive and resulted in a better mutual
understanding of the position regarding the Company's development programmes.
The FDA has indicated that it is in the process of conducting a thorough review.
The Company will make further submissions in the coming weeks and will continue
to work with the FDA to lift the clinical hold.
A further announcement will be made as and when appropriate.
For further information
Allergy Therapeutics +44 (0) 1903 845 820
Keith Carter, Chief Executive
Tom Holdich, R&D Director
Landsbanki +44 (0) 207 003 3131
Shaun Dobson
Financial Dynamics +44 (0) 207 831 3113
Ben Brewerton
This information is provided by RNS
The company news service from the London Stock Exchange
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