30 DAY TIMER, NOT 1 MONTH
Post# of 5066
Dear Meach,
It appears to be another 30 day timer, not 3 month! 
From: SOPP 8201: Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications.
RESPONSE TO A SPONSOR'S COMPLETE RESPONSE
A letter to the sponsor from the FDA in response to a sponsor's complete response in which the sponsor (1) is allowed to proceed under the IND as proposed by the sponsor (i.e., the clinical hold is lifted), (2) is allowed to proceed with specific restrictions not proposed by the sponsor (i.e., a partial clinical hold), or (3) is informed that studies under the IND still may not proceed. In the latter two cases, the letter will set forth the reasons why the clinical hold is being maintained. This letter should be issued to the sponsor within 30 days of receipt of the sponsor's complete response.
THIRTY DAY RESPONSE CLOCK
FDA is required under the modernization act to respond in writing to the sponsor's complete response to a clinical hold within thirty days of receipt of the response.
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