Evidence items catalogued
142
across 13 SKUs · 3 Danone brands · 9 markets
Critical gaps
● RED11
vs HTA/ACFS reqs · 2029 product
White-space briefs
● AMBER5
P0 & P1 prioritised
HTA dossier readiness
● AMBER58%
for UK · DE · FR · IT
Evidence inventory · strength score (0–4)
| SKU | RCT | RWE | H-Econ | Safety |
|---|---|---|---|---|
| APT-PEP1-800 | 4 | 3 | 2 | 4 |
| APT-PEP2-800 | 4 | 3 | 2 | 4 |
| APT-PEPJR-450 | 2 | 2 | 1 | 3 |
| APT-SYN-400 | 3 | 2 | 2 | 3 |
| NEO-LCP-400 | 3 | 3 | 3 | 4 |
| NEO-SYN-400 | 3 | 2 | 2 | 4 |
| NEO-JR-400 | 2 | 3 | 2 | 4 |
| NEO-ACT-SCH | 2 | 2 | 1 | 3 |
| NEO-SPN-100 | 1 | 2 | 1 | 3 |
| CG-PEP1-800 | 3 | 3 | 2 | 4 |
| CG-PEP2-800 | 3 | 3 | 2 | 4 |
| CG-NPH-800 | 2 | 3 | 2 | 4 |
| APT-COMB-2029 | 1 | 0 | 0 | 2 |
Competitor evidence comparison
Gap analysis vs HTA / ACFS requirements
| Market | RCT | RWE | HEcon | Safety | HTA dossier |
|---|---|---|---|---|---|
| 🇬🇧 United Kingdom | |||||
| 🇩🇪 Germany | |||||
| 🇫🇷 France | |||||
| 🇮🇹 Italy | |||||
| 🇪🇸 Spain | |||||
| 🇳🇱 Netherlands | |||||
| 🇧🇪 Belgium | |||||
| 🇵🇱 Poland | |||||
| 🇸🇪 Sweden |
White-space briefs · 2029 combination product
WS-01P0
Combination product HEcon model (UK/DE)
Owner · HEORETA · Q4 2026
WS-02P0
RWE: real-world growth outcomes vs comparator
Owner · Med AffairsETA · Q1 2027
WS-03P1
Safety dataset extension – combination cohort
Owner · R&DETA · Q2 2027
WS-04P1
ACFS-specific nutritional adequacy submission
Owner · RegulatoryETA · Q3 2026
WS-05P2
Tender-grade cost-effectiveness one-pager
Owner · CommercialETA · Q4 2026