Thanks Wild. Concur with many of your thoughts, especially for the poor Pts who suffer from a very nasty Ca.
So what is the deal with the IDE? 'The company expects to file for an IDE with the FDA in 2016 Q4'
Why another delay? I suspect manufacturing, but that is just my view.
'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.
I'd rather see a broker report from Bell Potter or one of the larger respected houses. .
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