A 90-Day Roadmap: From Formula Screening to a §1114.7 Evidence Package
Answers: “PMTA evidence timeline roadmap 90 days”
Applicants often ask how fast they can move from a shortlist of candidate formulas to a submission-ready evidence package. Here is a realistic 90-day sequence that front-loads modeling and reserves empirical spend for the survivor.
The roadmap
- Days 1–15 — Screen. Run ELCR on existing HPHC data across all candidate formulas; rank by Σ ELCR vs. 1R6F. Drop the weakest.
- Days 15–40 — Model PK. Run 500-subject in-silico PK trials on the shortlist; compare Cmax/Tmax/AUC and prediction intervals.
- Days 40–65 — Model population impact. Run PHIA with dual tipping-point sensitivity; keep the formula with the most defensible net-benefit profile.
- Days 65–90 — Assemble. Export the §1114.7-formatted package (14–21 citations); begin confirmatory study planning for the chosen formula only.
Pros vs. cons. Pro: a disciplined sequence turns months of guesswork into a structured screen-then-confirm workflow, with modeled evidence in minutes at each stage. Con: 90 days gets you a modeling spine, not a complete submission — confirmatory studies and regulatory writing extend the true timeline.
Who should NOT buy: teams already mid-submission with formulas locked and confirmatory data in hand.
FAQ
Can I get a full PMTA in 90 days?
No — this produces the modeled evidence spine; confirmatory work follows.
What's done first?
ELCR screening, because it uses data you already hold.
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