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lakota6

8,832 Posts.

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08/09/19

10:58

Post #: 40352687
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Originally posted by Rock57 ↑

On the 27/3/18 GMV responded to an ASX query - link below

https://www.asx.com.au/asxpdf/20180327/pdf/43srnkq0bkmcgs.pdf

Can anyone advise what has happened between this asx query and response that has extended the approval of the clinical trial by 22 months (if in fact approval is received by Dec this year???? - I don't know and I want to know

Question 5 in the query was
Noting that GMV has been granted “green channel” approval by the CFDA,has GMV been granted regulatory approvalfor the Prizma medical smartphone case by the CFDA? If not, when does GMVexpect the regulatory approval for the Prizma medical smartphonecase to be granted by the CFDA?

The response was
No, G Medicalhas not yet been granted regulatory approval for the Prizma medical smartphonecase by the CFDA. The Green Channel granting is anacknowledgement by the regulators that G Medical’s submissions will be treated as a priority approval process
All technicaltests have been passed which is why the Green Channel was granted. Clinicaltrials are anticipated to be finalised within the next few weeks. G Medical’s final submission will then be lodged for CFDAapproval. It is on this basis that G Medical considersit has a reasonable basis to expect to receiveCFDA approval in the secondquarter of 2018,which it haspreviously announced. GMV willrelease a further announcement in due courseonce it receives updates from the regulator.

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It is fair question and one of the difficulties with dealing with regulatory approval in China.
If you look at other companies that are waiting for approval in China , you will find similar delays in dates.
One example is BAL , they have been waiting for the approval for their IF for nearly 2 years , with many announcements indicating that they expect the approval " in the near future "

GMV Price at posting: 8.1¢ Sentiment: None Disclosure: Held
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