triage - we have a way to go with the permitting - pre-validation negotiations with FDA, prep for validation study, recruitment, evaluation and submission of findings and application for market approval, FDA and other regulatory review.
My expectation is that we will know more in the next month - in terms of the outcomes of negs with FDA - design and timing of the validation study etc. That will give us much more clarity.
Re the current manufacturing pilot, my understanding is that many EMU'S are being built for additional trials in the USA - to assist with visibility in that market. This was announced recently with respect to Keysight's investment.
triage - we have a way to go with the permitting -...
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