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kabunushi

04/12/24 4:40 PM

#684890 RE: ccie1024 #684883

I didn't re-read their full statement but as I recall from memory, they were very clear that they had been trying out a few (maybe 4?) different prototypes but they settled on the one they plan to go with. This is clear because they say that after building GMP compliant version of the selected prototype their next step will be to use that finalized GMP compliant machine to collect the data needed to get RA approval for the device. The OP's quoteStates pretty clearly that the prototyping is completed. It's not even stated but clearly the only further 'development' work might come only if any unexpected issue with the validation runs requires any further tweaking (not expected but until they have the full dataset for approval in hand, the finalized prototype just might need some final tweeking.
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beartrap12

04/12/24 7:12 PM

#684901 RE: ccie1024 #684883

No, ccie, these are the commercial-grade, clinical-grade units that the manufacturer is building, not prototypes. Either MHRA requires that the engineering runs are made on more than one unit or the company is that certain that the units will be approved, I assume.
Bullish
Bullish