Let’s see, is it going to be hard to prove that
Post# of 145797
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Let’s see.
The FDA doesn’t think they did it correctly, even though the FDA gave them specific guidance how to correct the deficiencies. Amarex failed to follow the FDA”s explicit instructions for the 2nd opportunity to file.
The 3 auditors think that Amarex did not create usable data.
Golly — gee — will Amarex saying “but we did it right, honest” prevail over the FDA and 3 auditors’ opinions?
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