Not likely M123. They will either clear it or request more info....

Not likely M123. They will either clear it or request more info.

[CDER will review and respond in writing to the sponsor’s complete response to an IND clinical hold within 30 calendar days of receipt of the sponsor’s complete response. ! If the sponsor’s response to an IND clinical hold letter does not address all the clinical hold issues, the sponsor will be so notified, and the 30-day response clock will not start until a complete response is received.

Authority ! Authority to impose, release, and retain clinical holds on INDs has been delegated to division directors or acting division directors. This authority cannot be further down delegated.

Tracking ! CDER will maintain a monthly tracking system to track IND submissions, IND clinical holds, sponsor complete responses to clinical holds, and CDER responses to sponsor complete responses to clinical holds.]
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082022.pdf