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 vaccine. Drag to place yourself.

8 wk

1 wk26 wk52 wk

~1 month (4 wk): 8 of 12 precedents ran this long · 3 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 · Protein and VLP vaccines

Mostly in line

4 aligned · 2 heads-up · 1 differ

Species. 0 of 13 approved vaccines used the same set-up (monkey only). Most common: other species (6).

✓

Study length. You plan 8 weeks (~1 month (4 wk)); 8 of 12 precedents ran ~1 month, range 2–13 weeks.Evidence: , ,

✓

Genotoxicity studies. Your choice matches the majority: 8 of 13 precedents did the same.Evidence: , ,

✓

A carcinogenicity study. Your choice matches the majority: 11 of 13 precedents did the same.Evidence: , ,

✓

Dedicated reproductive tox. Your choice matches the majority: 11 of 13 precedents did the same.Evidence: , ,

First human dose. 0 of 13 vaccines disclosed how they set it. Decide early — it drives which tox data you need.

What reviewers will probe. Adjuvant-driven local reactogenicity: injection-site myofiber degeneration/necrosis and inflammation · TLR4-agonist adjuvant · Local and systemic inflammatory responses driven mainly by CpG 7909 immunostimulationEvidence: , ,