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 wasNo, 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.