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
Dan il- SAP jeħtieġ il- approvazzjoni tas- CHMP qabel l- implimentazzjoni sa Q1- 2008 • Jissottometti ir- rapporti ta ’ l- istudji kliniċi ta ’ l- istudji 20030167 u 20030250 inkluż l- analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q1- 2008 • Jissottometti ir- rapport ta ’ l- istudju kliniku ta ’ l- istudju PACCE (anke jekk interim) inkluż l - analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q1- 2008 • Jissottometti ir- rapport tas- sommarju ta ’ l- istudju kliniku ta ’ l- istudju 20050181 biex jikkonferma l- ipoteżi dwar KRAS tat- tip salvaġġ bħala biomarkatur għal għażla ta ’ pazjenti li għandhom jiġu kkurati sa Q4- 2008 • Jipprovdi tagħrif fuq il- Kwalità tal- Ħajja ta ’ l- istudji 20050181 sa Q4- 2008 • Jissottometti ir- rapport ta ’ l- istudju kliniku ta ’ l- istudju STEPP inkluż l- analiżi ta ’ sigurtà - effikaċja f’ relazzjoni ma ’ KRAS sa Q1- 2009 • Jissottometti ir- rapporti tas- sommarju ta ’ l- istudji kliniċi ta ’ l- istudji SPIRITT u PRECEPT inkluż l- analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q2- 2009 • Jissottometti ir- rapport tas- sommarju ta ’ l- istudju kliniku ta ’ l- istudju 20050203 inkluż l- analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q4- 2009. • Jipprovdi tagħrif addizzjonali fuq il- Kwalità tal- Ħajja ta ’ l- istudju 20050203 sa Q4- 2009 • Jissottometti ir- rapport finali tas- sommarju ta ’ l- istudju kliniku ta ’ l- istudju 20050203 inkluż l - analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q1- 2010 • Jipprovdi tagħrif addizzjonali fuq il- Kwalità tal- Ħajja ta ’ l- istudju 20050203 sa Q1- 2010 • Jissottometti ir- rapport finali ta ’ l- istudju kliniku ta ’ l- istudju 20050181 inkluż l- analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q1- 2010 • Jissottometti ir- rapport finali ta ’ l- istudju kliniku ta ’ l- istudju PACCE inkluż l- analiżi ta ’ sigurtà- effikaċja f’ relazzjoni ma ’ KRAS sa Q2- 2011