'There are a number of key milestones to focus on in the next 6 -12 months which include: approval of the CE Mark in the EU, start of sales in both the EU and other regions as well (Australia, Canada, Singapore), and the approval of the IDE by the FDA'
Any idea how they intend to generate sales in these regions, without phase 3 trials? Or are they referring to license sales to 3rd parties? The expectation of an approval of an IDE within 12 months appears a little aggressive as in the earlier section it states that they intend to file in Q4 2016.
Maybe the van Leeuwenhoek folks could provide a little more analysis and explain their thinking.
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