With respect Kogarahboy, that strategy does not make sense.
The FDA has agreed to study parameters involving 5 sites, at least 3 of which must be in the USA. This implies approximate parity between the sites in terms of workload contribution ie roughly 60 patients at each site.
It will take circa 6 months to complete the average of 60 at each site. Your proposed strategy implies, therefore, a 6 month delay in commencing the tials at 2 of the 3 USA sites.
In a recent announcement on the EMU production line, the Company indicated it could produce 1 unit per week, with this easily expandable to 3 units per week.
A more sensible strategy would be to use existing units where most needed (eg for training personnel in the new USA sites or early commencement at the existing Australian sites) while fabricating at least 2 new units so that all sites can commence asap after ethics approvals and legals are completed.
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