General Forum, page-808

FDA clearance update:
- approval could be up to few months away (even next Q)
- good news - continuous dialogue

• comparing Conneqt to previous approved device, so very low risk
• FDA reviewer is same as the one that cleared previous device

Will also look for CE mark, cFDA, TGA - etc once it has cleared FDA. The current order (latr last year), is for the current device, once this one is released, it will be additive as clinical trials will be able to move to hybrid model - readings in CRO offices and remote monitoring. Typically clinical studies are from people that reside 2 hours from a centre - this will allow a change to this, including very large trials.

Therefore will require a bit of patience from us - may be a good time to accumulate.