I read on page 17 of the RTF that the FDA issued a stop using the damn crayons and that if they continued they would be also graded on coloring outside the lines. But did Amarex listen? Nope… 6 months later they submitted another BLA with even more crayon corrections and aggressively distorted colored pictures that just reeked of crayon lemon scented smiley faces with tears flying everywhere.

Its like they were trying to be that rebel student that just won’t listen. They were sent back to explain to Nader just what they had lacked in completion of the BLA with another long list of corrections to make. It is like a revolving door in FDA communications and the only one able to figure this out would be Craigakess.