Based on recruitment experience to date, it will take 7 months plus to recruit the 300 patients at 5 sites. How much 'plus' will depend on the number of 'bleed' patients required as that takes much longer.
The pre-recruitment ethics approvals, clinical arrangements and personnel training will take some months. Then following the full recruitment there will be several months analysing the results and preparing marketing submissions to FDA.
That takes it to around Dec 2025. Then there is the FDA assessment timeline. Their goal is 180 calendar days but there is a wide range of actuals around that.
Based on the above, I'm setting my FDA approval expectations around mid 2026.
EMV Price at posting:
$2.00 Sentiment: Buy Disclosure: Held
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