Precedia/Check my plan

How does your package compare?

Five quick answers. Your plan is scored live against every approved precedent in your modality, with the regulator's sentence behind each finding.

01What are you developing?

We'll compare you with every approved product in this modality.

02Which species for pivotal tox?

Pick all that apply.

03Longest pivotal study

Each dot is an approved gene therapy. Drag to place yourself.

26 wk

1 wk52 wk104 wk

~6 months (26 wk): 15 of 26 precedents ran this long · 4 ran longer

04Which studies are you planning?

Toggle the ones in your plan.

05How will you set the first human dose?

We'll show the precedents that disclosed their approach.

Precedent fit · Gene therapy

Well within precedent

5 aligned · 2 heads-up · 0 differ

✓

Species. 12 of 26 approved gene therapies used the same set-up (rodent only). Most common: rodent only (12).Evidence: , ,

✓

Study length. You plan 26 weeks (~6 months (26 wk)); 15 of 26 precedents ran ~6 months, range 3–104 weeks.Evidence: , ,

✓

Genotoxicity studies. Your choice matches the majority: 21 of 26 precedents did the same.Evidence: , ,

✓

A carcinogenicity study. Your choice matches the majority: 26 of 26 precedents did the same.Evidence: , ,

✓

Dedicated reproductive tox. Your choice matches the majority: 20 of 26 precedents did the same.Evidence: , ,

First human dose. 4 of 26 gene therapies disclosed how they set it (0 activity-based, 2 tox-based). Decide early — it drives which tox data you need.Evidence: , ,

What reviewers will probe. Local urothelial toxicity of intravesical vector/Syn3 · AAV vector integration/hepatic oncogenicity · Off-target editingEvidence: , ,