Food and Drug Administration - December 1, 2005
Richard Klein and Kimberly Struble

After reviewing the current CCR5 antagonist development issue, the FDA CCR5 Antagonist Review Group and the Forum for Collaborative HIV Research have decided to postpone the meeting to discuss the long-term follow up of patients enrolled in CCR5 antagonist clinical trials until February or March of 2006.

The original January 18th date was chosen to address the long-term follow up issues in as timely a manner as possible. However, because additional clinical trial data is accumulating, waiting until as much information as possible is available will ensure that the public discussion is as effective as possible.

An announcement will be sent once the exact meeting date is established.

We still encourage input from the patient and advocacy communities and academia to ensure your suggestions and concerns are taken into consideration as we prepare for this important meeting.

Please use the website at http://www.hivforum.org/CCR5/index.html to provide input. Please provide your comments by January 15, 2006.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

051201
FD051202

SOURCE: Food and Drug Administration (FDA).

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