Possible catalysts
- Regulatory plan for CE/TGA and FDA approval developed; initial meetings with EU regulatory authority held in the UK;
Pre-production Felix device to be completed in December 2018 quarter;
Studies at University of Newcastle on equine semen progressing well for application of core technology to horses.
Key Opinion Leader facilities to commence using the Felix Device in Q1 2019
It is expected agreements for clinical assessment by selected KOL clinics will be entered into during the current quarter,
Memphasys senior management has had initial meetings in Europe with the EU Notified Body which will be responsible for assessing the Felix device for CE Mark approval. The meetings clarified the assessment process and confirmed that the Felix device is truly novel and that it would be a Class IIb for CE Mark and also for TGA approvals
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