it’s not as big of a deal as you’re making it out to be. The company originally thought it could be sorted quickly (without a meeting) but it has taken longer than they expected. We know there’s a meeting next month and then we’ll hear. The FDA moves slowly and there’s no precedent here for a phase 3 in PMS.
The core elements that actually matter (being able to go directly to phase 3) and the trial length (3 months) aren’t changed and are a massive improvement compared to the process for Trof where we had two phase 2, including a placebo control phase 2 and a much longer phase 3.
NEU Price at posting:
$13.41 Sentiment: Buy Disclosure: Held
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