I share similar views wrt the investment opportunity with EBR, and the fact that this delay to submission has only strengthened the likelihood for it achieving FDA approval sooner than later. And as John McCutcheon has stated many times, it is NOT a binary situation - it is more a question of the timing for approval.
I have very recently sought additional information regarding status of final module submission from the Company and had it confirmed that it remains on track for submission in Q3.
Wrt the battery issue I was reminded that the issue, in a very small sample of devices, was related to the Transmitter, but manifested itself as premature battery depletion - and there was no need for further testing wrt the battery.
Regarding the device verification program being completed, this is quite an extensive testing program. The Company highlighted the specific abrasion testing as an example, as that was the item that delayed the submission timelines. Notwithstanding this the submission remains on track for Q3.
I added a few more today and will continue to do so on price weakness.
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