So there needs to be a partnership (with an upfront component) during the pivotal trial otherwise they will need to raise more money. It isn't uncommon for this to happen but they're looking at a 1-year minimum time period after the trial is fully recruited, and then there's more time to prepare the application and awaiting the result. Realistically it is 18 months minimum to official FDA approval (assuming the results are good).
Ann: Capital Raise, page-2
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