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The European paediatric research network at the EMA (Enpr-EMA) (42) could be an appropriate platform for close interactions of all stakeholders necessary to facilitate the conduct of large long-term multi-centre studies in children to increase the availability of high-quality data in the field of SIT for the treatment of allergic rhinoconjunctivitis. This eventually will enable both patients and physicians to take evidence-based treatment decisions. We thank Beatrice Bilo, Susanne Kaul, Susanne Lau, Marek Migdal, Graham Roberts, Odilija Rudzeviciene, Franziska Rueff, Zsolt Szepfalusi AG-221 and Stefan Vieths for their participation at and contributions to the expert group meeting. We thank all members of the PDCO and the EMA paediatric team for their contribution to the standard Succimer PIP for allergen products for specific immunotherapy. The authors are grateful for the review of the manuscript by Agnes Saint Raymond. The views presented in this correspondence are those of the authors and should not be understood or quoted as being made on behalf of the European Medicines Agency or its scientific Committees. None. ""Worldwide, approximately 405 000 cases of oral cancer (OSCC) are diagnosed each year, with a rising incidence in many countries. Despite advances in surgery and radiotherapy, which remain the standard treatment options, the mortality rate has remained largely unchanged for decades, with a 5-year survival rate of around 50%. OSCC is a heterogeneous disease, staged currently check details using the TNM classification, supplemented with pathological information from the primary tumour and loco-regional lymph nodes. Although patients with advanced disease show reduced survival, there is no single pathological or molecular feature that identifies aggressive, early-stage tumours. We retrospectively analysed 282 OSCC patients for disease mortality, related to clinical, pathological, and molecular features based on our previous functional studies [EGFR, ��v��6 integrin, smooth muscle actin (SMA), p53, p16, EP4]. We found that the strongest independent risk factor of early OSCC death was a feature of stroma rather than tumour cells. After adjusting for all factors, high stromal SMA expression, indicating myofibroblast transdifferentiation, produced the highest hazard ratio (3.06, 95% CI 1.65�C5.66) and likelihood ratio (3.6; detection rate: false positive rate) of any feature examined, and was strongly associated with mortality, regardless of disease stage. Functional assays showed that OSCC cells can modulate myofibroblast transdifferentiation through ��v��6-dependent TGF-��1 activation and that myofibroblasts promote OSCC invasion. Finally, we developed a prognostic model using Cox regression with backward elimination; only SMA expression, metastasis, cohesion, and age were significant. This model was independently validated on a patient subset (detection rate 70%; false positive rate 20%; ROC analysis 77%, p