Denne SAP skal godkendes af CHMP inden implementering senest i 1. kvartal 2008 • At indsende de kliniske forsøgsrapporter for forsøgene 20030167 og 20030250 med sikkerheds - / effektanalysen i relation til KRAS inden 1. kvartal 2008 • At indsende den kliniske forsøgsrapport PACCE- forsøget (også en eventuel midlertidig rapport) med sikkerheds - / effektanalysen i relation til KRAS inden 1. kvartal 2008 • At indsende det kliniske forsøgsresumé for forsøg 20050181 for at bekræfte hypotesen om vildtype- KRAS som biomarkør for udvælgelse af patienter til behandling inden 4. kvartal 2008 • At udlevere data vedrørende Quality of Life for forsøg 20050181 inden 4. kvartal 2008 • At indsende den kliniske forsøgsrapport for STEPP- forsøget med sikkerheds - / effektanalysen i relation til KRAS inden 1. kvartal 2009 • At indsende de kliniske forsøgsresuméer for SPPIRITT - og PRECEPT- forsøgene med sikkerheds - / effektanalysen i relation til KRAS inden 2. kvartal 2009 • At indsende det kliniske forsøgsresumé for forsøg 20050203 med sikkerheds - / effektanalysen i relation til KRAS inden 4. kvartal 2009 • At udlevere yderligere data vedrørende Quality of Life for forsøg 20050203 inden 4. kvartal 2009 • At indsende det endelige kliniske forsøgsresumé for forsøg 20050203 med sikkerheds - / effektanalysen i relation til KRAS inden 1. kvartal 2010 • At udlevere yderligere data vedrørende Quality of Life for forsøg 20050203 inden 1. kvartal 2010 • At indsende den endelige kliniske forsøgsrapport for forsøg 20050181 med sikkerheds - / effektanalysen i relation til KRAS inden 1. kvartal 2010 • At indsende den endelige kliniske forsøgsrapport for PACCE- forsøget med sikkerheds - / effektanalysen i relation til KRAS inden 2. kvartal 2011
This SAP would need CHMP approval prior to implementation by Q1-2008 • To submit the clinical study reports of 20030167 and 20030250 studies including the safety-efficacy analysis in relation with KRAS by Q1-2008 • To submit the clinical study report of PACCE study (even if interim) including the safety-efficacy analysis in relation with KRAS by Q1-2008 • To submit the clinical study summary report of 20050181 study to confirm the hypothesis on wild-type KRAS as a biomarker for selecting patients to be treated by Q4-2008 • To provide data on Quality of Life of 20050181 study by Q4-2008 • To submit the clinical study report of STEPP study including the safety-efficacy analysis in relation with KRAS by Q1-2009 • To submit the clinical study summary reports of SPIRITT and PRECEPT studies including the safety-efficacy analysis in relation with KRAS by Q2-2009 • To submit the clinical study report summary of 20050203 study including the safety-efficacy analysis in relation with KRAS by Q4-2009. • To provide additional data on Quality of Life of 20050203 study by Q4-2009 • To submit the final clinical study summary report of • 20050203 study including the safety-efficacy analysis in relation with KRAS by Q1-2010 • To provide additional data on Quality of Life of 20050203 study by Q1-2010 • To submit the final clinical study report of 20050181 study including the safety-efficacy analysis in relation with KRAS by Q1-2010 • To submit the final clinical study report of PACCE study including the safety-efficacy analysis in relation with KRAS by Q2-2011