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clock Created with Sketch. 12/03/20
10:02
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Originally posted by Red bar
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LOL I see all of the told you so brigade beating their chest on this forum. Where were they when they were saying no CE certification or TGA CLEARANCE after achieving it? Facts it's not over until the fat lady sings! The FDA have left the door open for us to pursue. Our device remains as a class 3 Medical device at this stage even though it's obvious it is a class 2 medical device. To suffice the FDA we should submit a PMA FIRST! We need to ensure the FDA the device is safe and effective for intended use. We should ask this question? Spoke with Tony yesterday regarding my thoughts. He was very calm cool and Collective, he obviously knows more to this story then he is letting on. Hopefully he can tell us a little more in this investor conference call today. I know he told me yesterday over the phone that they will be having a meeting with the FDA and Experian group he believes he can quite easily answer most of the questions and the other questions will require a little more detail but he's very confident that he can answer everything... it's very odd that the FDA didn't just issue another set of questions for a company to respond to rather than just not Grant our application and get us to start pretty much from scratch again. It's shi* house I know but it is what it is.... thankfully if re-lodgement needs to take place Tony believes they can Lodge again within a week as all of the documentation is already prepared.. I say get your crap together lodge a PMA! Meanwhile bring in some bacon from the regulatory approved countries now to restore shareholder confidence moving forward. I'm looking ahead for clarity. If some matters can be cleared up today should see you nice rebound to at least above $0.10.. several other irons in the fire here other than FDA which gives me an incentive to hold and buy more down here..
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Thanks for the post. Any idea why Sanofi walks in the first place? And why did the announcement not include the fact that they are still in discussions with Sanofi? That is most unfair that only those who have the time to call gets extra info when this could have been easily included in the announcement.
