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Hopefully the next update from Craig will be an invite to...

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mikekiller

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23/07/22

11:08

Post #: 62688172
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Originally posted by writer: ↑

Hey kickit2me,

Another thing worth noting in the MST interview were Craig's comments around the FDA process.

13:20:

'We're ready to go. Once that's in - the 510k - and we've received initial comments back from the FDA which normally is within 30 days, we'll start production, as long as there are no material questions we need to follow up on. We don't believe there will be. We've done this multiple times before it's nothing new for us, same submission for the Oscar2 our other device with SunTech, and the Xcel - AtCor SphygmoCor Xcel - so we're anticipating a late November launch.'

30 days puts the submission process somewhere between Day 15 - FDA has conducted the Acceptance Review and notified the company that the 510k has been accepted for Substantive Review - and Day 60 where the FDA has conducted the Substantive Review and communicates to the company that they will proceed to the final step of Interactive Review - or ask for additional info.

Given the FDA's strict timelines, and in the absence of anything to the contrary, it's not unreasonable to think we're through the Acceptance Review and into the Substantive Review.

Unless there are general Covid-related delays with FDA and the 30 days Craig mentions is the old 15 Days.

Either way, 30 days is next is more or less next week, which ties in with the Q. If all is proceeding as expected, you'd think Craig will be keen to give a progress report in the Q, if he can.

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Hopefully the next update from Craig will be an invite to shareholders via a webinar with possibly a Q&A.
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CDX Price at posting: 41.0¢ Sentiment: Buy Disclosure: Held
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Hopefully the next update from Craig will be an invite to...

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