Author Topic: ARC requests approval of NT-proBNP as a biomarker in clinical trials  (Read 3979 times)

patpinchin

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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
Pat

Miriam Vered

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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.

patpinchin

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Thank-you Professor Hawkins and Miriam.
Pat