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Re: Evaluate post# 253179

Monday, 11/25/2019 1:41:56 AM

Monday, November 25, 2019 1:41:56 AM

Post# of 732189
A lack of comments after a given number of days IS Approval. I guess you did not understand that this has been discussed for many months. The same “approval” process applies to INDs. Don’t assume they will not have any comments if they don’t want to make them, and as with an IND, lack of comment/approval does not actually mean the FDA agrees, until it sees the data, or, prior to an actual trial a company gets a special protocol assessment, which ALSO is not an actual guaranty that they agree ... These agencies always reserve all options to themselves.
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