I realise this is an older thread but seemed the best place for...

I realise this is an older thread but seemed the best place for this. I know everyone here is convinced that FDA approval is virtually guaranteed, presumably from this https://jamanetwork.com/journals/jamaoncology/fullarticle/2497879 paper stating 100% correlation between ODAC results and FDA approval (41/41).

Thought this was worth posting as well given it is a more recent paper on the same topic. https://link.springer.com/article/10.1007%2Fs43441-020-00194-4

I don't have access to the full paper but from the abstract it seems the FDA has not approved 6 applications in which ODAC voted in favour of. Does anyone here have full access to see which cases they are referring to? Seems to indicate approval might not be as guaranteed as we would like.