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Posted On: 11/03/2022 5:40:13 PM
Post# of 148899
Re: craigakess #130105
Let’s see, is it going to be hard to prove that Amarex did not do the work in a professional manner as the contract specified, but rather was grossly negligent in not obtaining usable data (and, not in a timely fashion?)
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?
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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