Their subsequent decision ignored that overwhelming recommendation which suggests that their decision was already made and they had hoped that their briefing notes would be supported by that committee.
My sentiments exactly @yelrom. My question to OP is the reason behind the ‘ false expert panel’ over-ruling.
This shows they was interference between the two bodies, the panel and the decision makers.
Silviu referenced this in a comment around waiting for a different FDA board.
@otherperspective , @Ratfink, Why?
Sorry if this is coming across as being a bit pedantic. I won’t say anymore
USD573M in retained losses and a less than great 2020!. 2021 a year that cannot get worse, page-291
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