On 10 March Biovica announced that it intends to submit a 510(k) FDA application for market approval of DiviTum in Q3’20e (prev. mid-2020e).
The ~1 quarter delay is due to delivery delays from a component supplier. These issues have now been resolved, but mean that the analytical validation will not be completed until Q2’20e (prev. late Q1’20e). Biovica’s long-term ambition will be to revise its supply chain after completion of the 510(k) process.
The company highlights that the analytical validation so far has met its requirements and that close to 3/4 of the lots have been analysed. Importantly, all the ~1,500 SWOG samples for publication (the foundation for the FDA application) have been now analysed and the results are expected shortly.
Link to research:
https://www.introduce.se/foretag/Biovica/Equity-research/2020/3/biovica---progress-despite-slight-fda-application-delay/
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