A delay is a delay. Imho any delay is significant.
If the FDA did not have one (or more) significant concerns, they could have just gone ahead and approved Twirla, even with a black box warning if necessary. They already had cover to take this action from their ADCOM meeting.
Of course this doesn't mean that Twirla won't be approved (with or without a black box warning) once the FDA has had time to review the new info Agile is supplying.
In the meantime, holders of AGRX have some hard decisions to make. Hold strong? Sell and re-enter in a couple months? Or just sell and move on to another play?
No easy decisions here imho. Even the shorts have somewhat similar decisions to make.
Disclaimer: I am currently neither long nor short AGRX shares although I am closely following this stock for a possible entry in the future.
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