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3.9¢ g medical innovations holdings limited

Nothing in today's update on CFDA approval for the case - must...

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Rock57

7,192 Posts.

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11/05/18

16:47

Post #: 33043588
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Originally posted by Rock57 ↑

In regard to CFDA approval for the smart case this has been clearly stated to the market it would be achieved in April/ May 2018. If this has changed to Q3 18 which I read as July to September 2018 than they have breached disclosure rules as they should have put out an announcement as soon as they knew that to be the case??????

If it is now back that far than it is rubbish

Annual Report December 2017
CEO Letter (page 5)
FDA and CE approval
We received FDA clearance and CE approval for the PRIZMA, and CE approval for the VSMS/GMP (pending FDA approval). We also submitted multiple FDA and CE applications for different product functions and they are expected to be approved in the next few months.

G Medical was also one of 11 companies to receive Green Channel approval, which is a major milestone as it will expedite our CFDA approval, which is expected in April/May 2018. We have also passed all CFDA technical lab tests and regulatory tests and are in the final stage of clinical tests.

ASX announcement 5^th Feb 18
Mobile and e-Health company G Medical Innovations Holdings Ltd (ASX: GMV) is pleased to announce that its China - based subsidiary has been granted acceptance to the Green Channel expedited Guangdong Provincial CFDA (China Food and Drug Administration) regulatory approval process for Prizma medical smartphone case.

ASX announcement 4^th April 18
China Food and Drug Administration (CFDA) Green Channel
We recently announced that our China - based subsidiary has been granted acceptance to the Green Channel expedited Guangdong Provincial CFDA (China Food and Drug Administration) regulatory approval process for our Prizma Medical Smartphone Case. This is a tremendous endorsement and comes with additional benefits as outlined previously in the ‘Green Channel’ ASX announcement. While the CFDA itself is undergoing changes in structure and reporting within the Chinese government, we remain in ongoing communication with them and remain unaffected by these changes and on track as initially reported. In addition to our Chinese management team being in regular contact with them, I personally met with CFDA representatives two weeks ago in China and was positively encouraged by our dialogue. We anticipate receiving CFDA approval on our new manufacturing facilities soon after, being fully operational in May

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Nothing in today's update on CFDA approval for the case - must still be due this month?

GMV Price at posting: 27.5¢ Sentiment: Sell Disclosure: Held
2 Upvote

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