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Post# of 178140
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Sunday, 01/31/2016 6:02:58 PM

Sunday, January 31, 2016 6:02:58 PM

Post# of 178140
Toxic debt being cleaned up means nothing if you aren't submitting to the proper FDA classification group. FDA said they dont believe denovo will work in the denial letter.

FDA suggested human clinical trials for radiogel and also said they dont believe denovo would work because of the risk level of the product. Both of those are verifiable with government links . So why would amic still submit a denovo against the fda's recommendations?
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