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fbg0316

03/23/17 3:30 PM

#16434 RE: tx_farmer #16430

Tx Farmer, where did you get those other added timeline references? I just saw that the accelerated application receives an opinion in 150 days/5 months, so if they submit the application by July we should have an approval (or not) by the end of this year.

hovacre

03/23/17 3:36 PM

#16436 RE: tx_farmer #16430

I don't think you quite understand the dynamics of the process re: stock price appreciation. Speculation will certainly build even before submission of the MAA, let alone imminent potential approval.

Note also that orphan designation and high unmet needs often will cause the regs to move more quickly. I can't say with certainty how long things will take once they're rolling. But if you're trying to sow an impression of "there's nothing to expect until 2018," then you must be new to this.