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Jonathan Robinson

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Jonathan Robinson

Re: DewDiligence post# 92961

Monday, 03/22/2010 11:01:05 PM

Monday, March 22, 2010 11:01:05 PM

Post# of 257253
Quick comment:

FDA obviously knows the full detail of the mfg process for Copaxone. They had to approve it as part of the approval. Can the reviewers of the ANDA get access to this information? If so, they will know what the differences in process are.

Jon
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