I agree @sarge17, application for ROW rights following FDA approval would be prudent:
1. NEU can learn from the Acadia submission, and take useful components to assist with the submissions in other jurisdictions.
2. With FDA approval already completed, the other regulatory authorities may also leverage the existing approval and not have to repeat the investigation/analysis.
3. It would prima facie place NEU in a stronger negotiating position, where hitherto uninterested parties may require FDA approval as a condition precedent.
I don't share @TripAces opinion that ROW negotiations will be completed so soon. 6 months may actually be quite fast for such an important final decision (there'll surely be exhaustive due diligence on both sides).
A short-term delay in revenue flow may be worth a better final outcome.
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