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.
The 2018 annual report and AGM presentation forecast FDA...
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38.0¢ |
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Mkt cap ! $86.31M | |||
| Open | High | Low | Value | Volume |
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| Price($) | Vol. | No. |
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