Afternoon, I have not attended a shareholder update telecon, so...

Afternoon,

I have not attended a shareholder update telecon, so excuse my ignorance (if you can), but are the specifics of the program discussed, e.g.

* planned completion date of verification and validation (to do this one needs to have basically finished developing the Device);

* target date for submission of 510K for APAS Independence (no 510K means no sales, not in the US at least), and a similar question re Declaration of Conformance and CE Mark if Europe is the first port of call;

* target date for commencing Low-Rate Initial Production and what volumes / month (vital if the Contract Manufacturer is to gear-up in advance (or face potentially lengthy delays whilst parts are procured / manufactured)).

Without clarity on these, timing on sales / delivery may be problematic, unless the buying entity is entering into a sales agreement prior to achieving these milestones - the first two at least. Even if they do enter into such an agreement, the manufactured product still needs to trundle off the production line so what's the engineering program plan looking like, where are the milestones, what are the dates? Then, when is the regulatory certification slotted for?

Away from 'sales agreements' most of the above should be know by LBT as this is medical device development / engineering / project management basics.

So, does any of this get shown / sighted / etc. or is it not available / not relevant / something else?

Cheers