it seems that what wisebuys posted seems correct though pg. straight from the horses (FDA) mouth. we do have a proposed clinical investigation.

I. INTRODUCTION
Under Food and Drug Administration (FDA) regulations, an investigational new drug application (IND)
is either allowed to proceed or placed on clinical hold (21 CFR 312.42). A clinical hold is an order
issued by the FDA to the applicant to delay a proposed clinical investigation or to suspend an ongoing
investigation. A clinical hold may be designated either a complete clinical hold or a partial clinical
hold. An applicant may respond to a clinical hold. Once the applicant has submitted a complete
response to the clinical hold, the Agency must evaluate the response and decide whether to lift the hold.
The Agency has committed itself to respond to the applicant within 30 days. This guidance is intended
to describe how applicants should submit responses to clinical holds so that they may be identified as
complete responses and the Agency can track the time to response