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Author Topic: ARC requests approval of NT-proBNP as a biomarker in clinical trials  (Read 5157 times)

patpinchin

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ARC requests approval of NT-proBNP as a biomarker in clinical trials
« on: July 20, 2016, 07:38:18 pm »
Hi Miriam,

Encouraging news for cardiac patients. See link below.

If FDA approval is given for the use of NT-proBNP as a biomarker,  is it likely to apply to the two current studies for NEOD001 at the NAC?

Is NT-proBNP an approved biomarker for clinical trials in the UK?.

http://finance.yahoo.com/news/amyloidosis-research-consortium-announces-publication-152700555.html
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Miriam Vered

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Re: ARC requests approval of NT-proBNP as a biomarker in clinical trials
« Reply #1 on: July 21, 2016, 09:02:13 am »
Professor Hawkins' answer: It remains to be seen how the FDA and EMA will view cardiac biomarkers as a trial endpoint, this ultimately being tested when the results of a trial are submitted to them.
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patpinchin

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Re: ARC requests approval of NT-proBNP as a biomarker in clinical trials
« Reply #2 on: July 21, 2016, 01:25:54 pm »
Thank-you Professor Hawkins and Miriam.
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