OH THIS IS RICH! PRAY TELL WHAT ARE THE SECRET CONCERNS, LOL. TOO FUNNY!!!
To the unsophisticated, the FDA solicited an amendment first disclosed in last Friday’s filing. This isn’t a bad thing. Any analyst worth a salt still believe approval is on track once LABELLING is resolved—see William Blair’s Tim Lugo comments earlier today.
If the FDA wanted this nuked, they would have issued a CRL, effectively killing Twirla. They didn’t.
This gets resolved sooner than most people think, IMO.
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