"The FDA review team has 30 days to review the original IND submission... A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study." This is a direct quote from the FDA on timeframes of clinical trials and preparations. Of cours, this can take extra time, but for most, this is how it is, and Tetra has a very good working relationship with FDA and Health Canada throughout this process and they have a team and patners as well with much experience working with FDA and HC. I wanted to make sure readers are aware of the FDA's own comments.