Good quarter of growth but we are all waiting for the TGA announcement. The review is ongoing so we continue to wait and hope.
We continued to work with Australia's Therapeutic Goods Administration (TGA) on its regulatory review intended to permit Hydrix to market and distribute The Guardian in Australia. There is no statutory timeframe mandated within which the TGA must complete the application review process for Class III implantable devices and we are unable to advise an outcome date
Good quarter of growth but we are all waiting for the TGA...
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