Many first-time sponsors set a target first-dose date before mapping the CMC, nonclinical, regulatory, clinical-supply and site-startup work that has to converge on it: often 12 to 24 months or more, depending on the product. Enter your status in each workstream and see an illustrative readiness pathway, which activities would already need to be underway, and what would change the answer. Statutory requirements, reported performance metrics, CadenceAI planning assumptions and your own overrides are labelled separately.
Each workstream runs in parallel and is tracked separately. Answer them independently.
Months before target first dose. Ranges are low / most likely / high. Editing the middle value marks that row as your override and the calculation uses your number. The regulatory review duration and the clearance-to-first-dose buffer are edited separately: the first is a regulatory clock, the second is a CadenceAI planning assumption. Regulatory source notes identify calendar versus working-day requirements where applicable. The pathway itself uses approximate month-based planning offsets and does not convert official regulatory clocks exactly.