This update finds us AGAIN in an urgent state of need. We ask that you AGAIN send your feedback to the FDA regarding Eteplirsen! The FDA Meeting is rescheduled to 4.25.16 and all testimony must be in by April 11, 2016.
We ask that you Act Now and send your letter – you can send the same letter you sent in January – please help us and send this again.
Are you in??? If so – Keep Reading then ACT!
We have seen amazing improvements in Owen since he started this medicine on April 10, 2015. Some of you have seen firsthand these improvements. He is on week 50 of his infusion and we witnessed him moving his head from one side to another while lying on his belly… this is something he stopped doing YEARS AGO! Neck Muscles are back baby!!
Your witness to his new abilities & STRENGTH is what you need to write the FDA about! For those that have not seen Owen of late, you have witnessed through these updates all the amazing tasks he is doing as he gains strength right before our eyes!
You can feel free to write from your heart about why it is so critical for the FDA to allow this New Drug Application (NDA) to pass. Many more boys can benefit immediately if this drug is approved and your written statement can be the one that derails the path of Duchenne in our boys!
We thank you in advance for your willingness to submit this urgent statement – please send this on to everyone you know, in every form of media (email, social, text, heck pick up the phone and call!) and ask them, on behalf of John Owen Dumm and John Owen’s Adventure, Inc, to submit their plea.
Send your email to: PCNS@fda.hhs.gov
Email subject line: Written testimony submission for FDA Advisory Committee Meeting to consider Eteplirsen – April 25, 2016
Attn: Moon Hee V. Choi
‘The following is my written testimony submission for the FDA Advisory Committee Meeting to consider Eteplirsen – April 25, 2016.”
Here is a sample of what to write OR you can write in your own words (as long as the above is included)
Dear Ms. Moon Hee V. Choi
The following is my written testimony submission for the FDA Advisory Committee Meeting to consider Eteplirsen – April 25, 2016. I am writing on behalf of John ‘Owen’ Dumm (12) who has Duchenne Muscular Dystrophy and his foundation, John Owen’s Adventure, Inc. Owen started the Sarepta Trial 204 on 4.10.15. He has experienced zero negative side effects from being on this drug.
I have memories of Owen before this muscle killer robbed his legs from walking and before this killer took full hold of the rest of his muscles. I remember him XXXXXXXX (HERE IS WHERE YOU CAN ADD YOUR EXPERIENCES – for instance, walking in the halls at school, playing in the creek with his brothers, playing the games at his annual fundraiser, JOA Picnic in the Park). Duchenne has brutally taken away these abilities in Owen. I thought that once these muscles were gone, they would be gone forever.
This, however, all changed when Owen started this trial. From all reports he has had ZERO negative side effects. (IF YOU HAVE PERSONAL EXPERIENCE LIST OUT ALL YOU HAVE SEEN HERE….) I have witnessed the muscles that were weak, get stronger when Owen XXX XXXX (EXAMPLES – LIFTED HIS FORK TO HIS MOUTH – MOVED HIS BOOKS ON HIS DESK - SAT UP STRAIGHT IN HIS WHEEL CHAIR – BENT DOWN AND SCRATCHED HIS LEG….)
This drug is working in Owen. Eteplirsen has proven to be safe in him and in other boys. I urge you to consider the safety and effectiveness of this drug and insist on the approval of the NDA before one more day goes by and yet we lose one more boy to this muscle killer.
Exon Skipping is a game changer for our Duchenne boys. It is clear from the abilities shown in our Owen that this therapy works. It will work for all boys that can benefit and approval of this drug will open the doors to cure not just these boys, but all that will benefit from Exon Skipping, in this generation and the next.
I fully understand it is your duty to complete this due process. It is also your duty to supply our citizens with drugs that are safe and effective. Eteplirsen is both and therefore it is your duty to approve this drug immediately, Now is the Time!
I thank you for your consideration.
Please join us on April 9 for our 4th Annual Play for JOA from 130pm-430pm – it is always a great time. Plan on it!!
Tony, Jen, Rutger, Owenand Wade!!! xoxoxoxxo