Ann: Final Sofdra Labelling Discussions with FDA, page-196

Correct.

If BOT mistakingly loaded their printer with portrait....and never bothered to check.

If BOT forgot to include the human factors test results they conducted as part of the response.... and nobody checked.

If the instruction packer wrapped the instructions instead of folding, and everyone forgot to check that CRL item too,

Or they uploaded the old label picture, and printed without anyone in the team actually checking what was printed in the last 6 months, despite the entire company being focussed on that.

I bet even a 6 year old could have followed up on the CRL print and package items with a list of instructions...

The surest FDA approval anyone has seen pre approval.

Go ahead.... buy in the day after approval along with all the others, and the managed funds and super schemes, then the only way is sky-rocketing up and no possibility of a tank.

Of course it will tank if FDA don't approve, and if my grandma had wheels she would be a bicycle