Replies to post #12914 on FDA Plays

[oldberkeley]

it’s common for applicants to submit additional data during an FDA review

Dew- And since the additional submission is at the discretion of the company, they'd be careless—if not negligent—in not submitting additional positive data.

And if negative, I assume that they could play the dangerous game of hoping it’s never asked for?

As usual, TIA for your expertise.