Old 02-25-2013, 04:07 PM #1 (permalink)
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Default Congratulations to the 60 speakers

At the FDA hearing today, our voices were heard loud and clear. Heartfelt pleas were voiced to the FDA. Particularly well spoken were Ted Harada speaking for himself and all ALS patients and being the voice for Col Scott Johnson. Well done everyone! We especially appreciate those who are able to still travel and can voice in person our thoughts and wishes. FDA: it is now in your ball park. Please review the tape of those speakers and DO THE RIGHT THING. TIME IS NOT OUR FRIEND!
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Old 02-25-2013, 06:36 PM #2 (permalink)
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Default Re: Congratulations to the 60 speakers

I caught bits and pieces of the broadcast. Our representatives did a wonderful job. It gave me hope that changes in the system will come soon.
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Old 02-25-2013, 09:37 PM #3 (permalink)
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Default Re: Congratulations to the 60 speakers

I hope, I hope.
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Old 02-26-2013, 09:21 AM #4 (permalink)
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Default Re: Congratulations to the 60 speakers

Job well done. Congrats to all ! ! !
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Old 02-26-2013, 09:48 AM #5 (permalink)
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Default Re: Congratulations to the 60 speakers

I firmly believe the testimony made a difference. There was a great deal of notetaking, and one of the panelists personally thanked me for my testimony. I think we got across the point that we will accept more risk, and that eliminating BiPAP patients from the trials is ludicrous. All of the panelists were physicians and I don't think this was easy for any of them to listen to. But listen they did. I'm glad they set up remote access so everyone could hear.
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Old 02-26-2013, 03:36 PM #6 (permalink)
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Default Re: Congratulations to the 60 speakers

Thanks to all who represented us.
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Old 02-26-2013, 09:27 PM #7 (permalink)
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Default Re: Congratulations to the 60 speakers

hope they do change the criteria for drug trials. just finished year long trial of rasagiline. was asked to review protcol of next phase and recommended expanded criteria. returned comment was if they went past 3 years the individual may not be able to finish the test. if this is true and the drug becomes approved for als would this indicate anyone diagnosed over three years should not buy it
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Old 03-07-2013, 08:12 PM #8 (permalink)
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Default Re: Congratulations to the 60 speakers

Quote:
Originally Posted by retiredmus2010 View Post
At the FDA hearing today, our voices were heard loud and clear. Heartfelt pleas were voiced to the FDA. Particularly well spoken were Ted Harada speaking for himself and all ALS patients and being the voice for Col Scott Johnson. Well done everyone! We especially appreciate those who are able to still travel and can voice in person our thoughts and wishes. FDA: it is now in your ball park. Please review the tape of those speakers and DO THE RIGHT THING. TIME IS NOT OUR FRIEND!
Any follow up on that regard?

Thanks,

NH
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Old 03-09-2013, 06:20 AM #9 (permalink)
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Default Re: Congratulations to the 60 speakers

My guess is that we'll hear from the FDA after the open comments period ends Mar 25.

If you have not left comments, please do so at Regulations.gov

Voices of those with ALS and caregivers are especially important, especially since we learned that a Knopp v Biogen Idec lawsuit was being filed on the very day we were testifying to the FDA. As we promoted collaboration, they decided to duke it out in court.

Please comment to the FDA. If you have ideas about new ways to do clinical trials, please speak up. If you want them to listen directly to PALS and CALS in the future, please speak up.

Thanks, all.
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Old 03-09-2013, 02:54 PM #10 (permalink)
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Default Re: Congratulations to the 60 speakers

Thanks.

I already left comments for them to read before the scheduled meeting.

Regards,
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Old 03-12-2013, 09:53 AM #11 (permalink)
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Default Re: Congratulations to the 60 speakers

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Originally Posted by pearshoot View Post
hope they do change the criteria for drug trials. just finished year long trial of rasagiline. was asked to review protcol of next phase and recommended expanded criteria. returned comment was if they went past 3 years the individual may not be able to finish the test. if this is true and the drug becomes approved for als would this indicate anyone diagnosed over three years should not buy it
Probably not pearshoot...

It's probably because they are reluctant to let those with ALS past that point in because of the 'supposed' timeframe folks with ALS have.

They don't want their people to pass away during the trials. I know that sounds awful--but I'd bet that's the reason they have the absurd criteria--same with the bipap.

People still need to be alive at the end of the trial for them to get their required data.

They don't stop to think that things like bipaps, PEGS and diaphragm pacers have extended that life expectancy.
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Old 03-16-2013, 06:16 AM #12 (permalink)
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Default Re: Congratulations to the 60 speakers

The open comments period to the FDA continues only until March 25. Please speak up and submit your comments to the FDA online!

Regulations.gov

Only a few hundred comments have been submitted so far. We need thousands more in order to make an impact on the FDA. Please speak up. Thank you.

p.s. If any ALS organizations lurk here, please, please use the power of your reach to spread the word. We'll have no right to complain about FDA policies later if we've not taken advantage of this opportunity to comment directly to the FDA.
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Old 03-17-2013, 06:08 PM #13 (permalink)
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Default Re: Congratulations to the 60 speakers

Quote:
Originally Posted by rknt50a View Post
The open comments period to the FDA continues only until March 25. Please speak up and submit your comments to the FDA online!

Regulations.gov

Only a few hundred comments have been submitted so far. We need thousands more in order to make an impact on the FDA. Please speak up. Thank you.

p.s. If any ALS organizations lurk here, please, please use the power of your reach to spread the word. We'll have no right to complain about FDA policies later if we've not taken advantage of this opportunity to comment directly to the FDA.
I already submitted my comments after filling out the form.
Although, it wouldn't be right to fill out twice if you already did so.
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Old 03-18-2013, 06:43 AM #14 (permalink)
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Default Re: Congratulations to the 60 speakers

I don't think that there's any problem with submitting additional comments if you've had a new idea or thought since your first submission.
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