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sts66

11/29/18 4:23 PM

#164075 RE: marzan #163747

I found the PDF - this is what the CRL says - I'll admit the word "may" is ambiguous, but I still believe AMRN would have to start from scratch if they wanted ANCHOR, which is a total waste of time and money:

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 314.65. You may also request an extension of time in which to resubmit the supplemental application. A resubmission must fully address all the deficiencies listed. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.