Ann: Percheron appoints Dr Cathryn Clary as Chief Medical Advisor, page-35

Please refer to the attached document. It's self-explanatory...
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold

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.

When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and given the investigational drug; patients already in the study are expected to be taken off therapy involving the investigational drug unless treatment continuation is specifically permitted by FDA in the interest of patient safety.