I would have expected all the problems had been ironed out before the US tests - after all these tests was the prove to the major markets of the world, this technology does work.
And get the much sort after US approval.
Lets also remember they had previously done tests in both Australia and Indonesia - is company now saying the tests in both Australia and Indonesia did not identify these problems?
Or are these new problems only picked up in the US tests?
For me, its one of two conclusions; either the company did not picked up the problems in previous tests or the technology has a long way to go, to prove it is ready.
Furthermore, there is the reputational damage: which US hospital will now participate in the next round of tests, after the recent press release from the company.
IMHO, its going to be a tough hill to climb - to prove to the market and the world, that it has the technology to do the job.
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