The 2018 annual report and AGM presentation forecast FDA approval in 2019. They haven't submitted yet, but had 'pre-submission dialogue' with the FDA last year and since reported good progress toward submission.
An investor wanting to get the CGT discount upon a sale after FDA approval would therefore want to look at buying soon, but perhaps traders don't aim for this.
In the meantime their sales seem to been increasing nicely and I believe they can already sell in Europe without restriction the enteric kit, with approvals in this region for other products likely this year.
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The 2018 annual report and AGM presentation forecast FDA...
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