Ann: Appendix 3G and Appendix 3H, page-18

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    I....like many others no doubt......after reading these transcripts are still trying to rationalise why the FDA made the ridiculous decision to ignore the overwhelming recommendation of their own 'hand picked' ODAC committee voting (9-1) in favour of approving Ryoncil......and provide a proven & viable successful therapy in the ABSENCE of any other VIABLE alternative !!!! ????? Was the decision purely based on incompetence or corruption........I can't imagine any other reason. Now fast forward 2 years.....MESO has been treating these poor kids off label...assuming no issues with great success you can't beat REAL TIME DATA surely ????....what is the freaking hold up ?????????
 
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