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Re: boston745 post# 7471

Saturday, 11/26/2016 12:19:24 PM

Saturday, November 26, 2016 12:19:24 PM

Post# of 41599
Yes Boston I recall seeing a chart where Cascade results looked somewhat superior in two categories and just slightly inferior in one, but I cannot find it now. IMO, AMDA's rebuttal to the FDA questions must have asked them to look at the advantages as they outweigh one statistical equivalent outcome in one of the comparisons to PEEK. Again, one has to wonder the amount of politicking is going on at the FDA, when you have a product that is approved in Europe but cant get past the FDA bureaucracy.
Given the results, I would rather have the surgeons and their patients decide what product is the best to use, rather than the FDA taking choices away. Whose back is it anyways?
AMDA possibly took the wrong path to approval from the beginning, but I do not know how they could have known better given the results of the comparison studies.
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