Huntington's FDA Trial

Folks- Please find below a message from the director of the DC/NOVA HDSA chapter. If you are available for this hearing please do attend!

Hello one and all --

I am writing to ask for your participation and help in order to try to get the FDA to approve tetrabenazine for the treatment of Huntington's Disease. We know from our researchers that tetrabenazine can help with the chorea brought on by HD. Now the drug is coming before an FDA Advisory Committee in just a couple of weeks -- a crucial step if we hope to get full approval from the FDA subsequently.

HDSA National has asked for our local community's help to make that happen. In order to do that, we need as large a contingent of caregivers, families and people with HD to attend this meeting in a show of support and speak in favor of the drug's approval. Full details are below. The hearing is scheduled for December 6th in Beltsville, Maryland and we hope to get a large turnout -- particularly during the open comment period from 1- 2 pm. Many of you may have already heard about this hearing last week but now we need to find out who might be able to attend.

If you can attend and plan to do so, please let Sean Luis know. Sean is with HDSA's Advocacy Office and he is trying to get a sense ahead of time of how many people will attend from this area. His e-mail is sluis@hdsa.org and his phone number is 800-345-4372 extension 226.

If you have questions, please don't hesitate to contact him or us. And please let us know as well. You can simply write back to my e-mail at MurreyJack@msn.com or you can reach me personally at 202-257-2696.

Finally, please spread the word to those in the DC/Virginia/Maryland area that you know who might not be on this e-mail list but would be interested in attending. We are still developing our e-mail list and we realize word of mouth is as powerful as anything we can do.

Here's more info from a bulletin sent out by HDSA National just a few days ago. It originally wanted to get a head count by this week but they will be just as happy to get confirmation of more names next week.

Thanks for your time and assistance.

Murrey Jacobson
President, HDSA Washington Metro Chapter

FULL MESSAGE TO FOLLOW:



-- 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@hdsa.org 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@fda.hhs.gov 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@hdsa.org 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.