CDX cardiex limited

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"At the AGM on 30/11/22... Craig mentioned there was a major...

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LeeKing

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08/03/23

10:04

Post #: 66654769
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Originally posted by Quiltman ↑

My guess, based on the timeline below and these couple of facts , with my assumptions explained.

1) At the AGM on 30/11/22, in response to my question about progress on the Pulse clearance, Craig mentioned there was a major meeting happening with the FDA lead reviewer and the CardieX team that very day in the USA. My assumption .... that was part of the substantive review process, and most likely when the Additional Information was requested. That has us in the "purple" box below. I'm assuming that our application had been thoroughly reviewed, and the request for Additional Information would have been an exhaustive one.

2) The change of the wording between the 4C report and the Half Yearly report, from "providing" to "provided" in reference to the additional information. My assumption is that we provided the information requested in 1) sometime in February, between these 2 reports. Let's go mid Feb as a date.

So, from 15/2, assuming the Additional Information supplied met the requirements of the lead reviewer, we should be 30 - 40 "calendar" days from that date.

So my guess is Tuesday 21/3 in the US, gets ASX release on 22/3

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"At the AGM on 30/11/22... Craig mentioned there was a major meeting happening with the FDA... that very day in the USA."

I didn't hear "major meeting". I heard something like, "We are in contact with the FDA all the time. In fact, we met today." But I don't think that detail impacts your suggested timeline.

CDX Price at posting: 25.5¢ Sentiment: None Disclosure: Held
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