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Update - FDA Hearing on Tetrabenazine Scheduled for December 6, 2007

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  • Jean E. Miller
    As most of you know the FDA will have a hearing for Tetrabenazine [TBZ] on December 6, 2007. This hearing will be a Open Public Hearing which provides
    Message 1 of 1 , Nov 2, 2007
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      As most of you know the FDA will have a hearing for Tetrabenazine [TBZ] on December 6, 2007. This hearing will be a Open Public Hearing which provides patients, caregivers, physicians, and advocates an opportunity to address the FDA Advisory Committee.

      This is an important meeting since it will be the first time a drug as gone before the FDA specifically for Huntington's Disease. Although this particular meeting addresses the impact chorea has on HD families, it will be the first opportunity for HD families to help educate the FDA on Huntington's Disease, itself, which might help us in future HD-specific drug approval requests that go before the FDA! So if you have experience with chorea and Tetrabenazine, I hope you will support this important hearing.

      Last week I sent out the request from Nancy Wexler asking for family support to this FDA hearing. Please note, if you haven't already sent in your comments on your experience with TBZ, the HDSA would like you send them to HDSA and/or let HDSA know if you will be attending the hearing and wish to address the FDA. For those unable to attend, the HDS will submit your letters as part of their testimony on behalf of our HD families.

      Thank you!
      Jean

      According to the below request from HDSA:

      Key Dates are:
      7 November 2007 [on or before] - You must notify FDA of your intent to attend the open hearings.
      21 November 2007 [on or before] - To submit your experience with TBZ to the HDSA and FDA
      6 December, 2007 - FDA Advisory Committee Hearing - Maryland

      Key contacts are:
      Darrell Lyons at FDA
      Email Darrell.lyons@...
      Fax 301-827-6776.

      Sean Luis
      HDSA Advocacy & Family Services Manager
      Email sluis@...
      Fax 212-239-3430
      =====================================

      From: Deb Lovecky dlovecky@...
      To: 'Jean E. Miller'
      Cc: sluis@...
      Sent: Monday, October 29, 2007 4:40 PM
      Subject: FDA Hearing on Tetrabenazine Scheduled for December 6, 2007

      -- FDA Hearing on Tetrabenazine scheduled for December 6, 2007 ---

      We have received confirmation that the FDA Advisory Committee hearing for Tetrabenazine (Peripheral and Central Nervous System Drugs) will take place on December 6, 2007 from 8:00 a.m. - 5:00 p.m. at the Sheraton College Park Hotel in Beltsville Maryland. The Open Public Hearing which provides patients, caregivers, physicians, and advocates an opportunity to address the Advisory Committee will take place from 1:00 - 2:00 p.m.

      Ideally we would like to pack the Ballroom at the Sheraton with as many HD family members as possible to show support for the approval of the very first drug specifically designated for HD. If you will be able to attend the Open Hearing, please contact Sean Luis, HDSA Advocacy and Family Services Manager, so we can continue to provide you with details about the meeting and how we can maximize our efforts. Email sluis@... or call Sean at 800-345-4372 extension 226.

      We invite you to provide written statements in support of Tetrabenazine that demonstrate how the drug helped you or your family member. Please send your written statements to Darrell Lyons at the FDA before November 21. Email Darrell.lyons@... or fax to 301-827-6776 and please also send a copy of your statement to HDSA so we may also provide them to the FDA during the hearing. Email sluis@... or fax 212-239-3430 attention Sean Luis.

      If you would like to make a presentation during the open public hearing (space will be limited), please contact Darrell Lyons before November 7th and include a brief statement about what you would like to present, your name and address, and indicate how long you would like to speak. Please let Sean Luis (see contact information above) know if you have submitted a request to speak so we can coordinate efforts to fully address the issues that individuals with HD affected by chorea face daily. It is important to give the FDA a face and voice for those who are affected by the chorea associated with HD.

      For those who previously sent letters to HDSA about the impact chorea has had on their loved one, we thank you. Please know that we will be submitting those letters as part of our testimony on behalf of our HD families.

      Please know that we will keep you apprised of all developments as they occur. Thank you for your assistance.

      [Non-text portions of this message have been removed]
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