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 A clinical hold is an order issued by FDA to the sponsor of an IND application to delay a proposed clinical investigation or to suspend an ongoing investigation. All or some of the investigations conducted under an IND application may be placed on clinical hold.(https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold)  

After the FDA receives the IND, an IND Acknowledgement Letter will be sent to the sponsor investigator. The letter includes important information such as the assigned review division, IND number, division contact, and the official FDA date of receipt. The latter is important because by regulation the proposed trial may not be initiated until 30 calendar days after official FDA receipt. 

The sponsor investigator should address these deficiencies in writing to the division with any requested data. If a sponsor-investigator of an IND that has been placed on clinical hold requests in writing that  the clinical hold be removed and submits a complete response to the issues identified in the clinical hold letter, the FDA will respond in writing to the sponsor-investigator within 30 calendar days of receipt of the complete response. The FDA’s response will remove, maintain,  or modify the clinical hold, and the letter will state the reasons for such determination. 

Notwithstanding the 30-calendar-day response time, a sponsor-investigator may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor-investigator has been lifted. 

In some situations, it may be unclear whether a change to an existing protocol or a new protocol should be communicated as an amendment to an existing IND or under a new IND, or if a new 30-day review period at the FDA is warranted. In such situations, the sponsor-investigator should seek case-by-case guidance from the relevant CDER or CBER review division to minimize the chance of an unexpected clinical hold.

  
 clinical hold에한 정의는 FDA사이트에서, 첫문장 이하는 첨부문서(8061dft.pdf)에서 발췌하엿습니다. 자세한 내용들은 첨부문서(8061dft.pdf)내용(15쪽~18쪽)을 참고하시길 바랍니다  그리고 IND관련 POLICY AND PROCEDURES 자료(6030.1.Rev2)자료도 같이 첨부 합니다 

일부 주주분 사이에 임상승인 일자에 대해서 설왕설래가 있는것 같습니다. 혹시 참고가 될까 하면 남겨 봅니다. 

윗내용에서 보시다시피 30일 규정에서 움직이는것은 맞으나 경우에 따라서 30일 규정을 벗어날수도 있음을 알수 있습니다.