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13:46
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Originally posted by Beale:
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YOU KNOW THEY HAVEN'T EVEN BOTHERED TO UPDATE THE MKT REGARDING THIS ANN DONT YOU. AND YES THE DATE OF ANN IS 6 DECEMBER 2017 .The regulatory review process is expected to take 12 months with approval of ZolpiMist anticipated in Q4 2018. Under the terms of the agreement with Teva, the approval of ZolpiMist triggers a milestone payment to SUDA.Based on a study to assess sleep disorders in the adult population of four largemetropolitan areas in the licensed territory, the prevalence of insomnia, was estimated to be 35%, with 15% of the surveyed subjects taking sedatives. This is a higher prevalence than in most other parts of the world.SUDA’s CEO, Mr Stephen Carter, commented: “We have been working hard with our partner Teva to expedite the submission of the first Marketing Authorisation Application for ZolpiMist. We are delighted that Teva has maintained its timetable of filing within five months from signing the licensing deal . There is a high prevalence of insomnia in the licensed territory and ZolpiMist offers patients a valuable treatment option with unique advantages compared to standard-of-care tablets.”
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Beale, I would add this - the SUD announcement regarding submission of the Teva Marketing Application on December 6 2017 was marked "price sensitive". Would it not then follow that the outcome of that application should also be considered "price sensitive" and therefore would be considered a required notification under ASX continuous disclosure guidelines? https://www.asx.com.au/documents/rules/gn08_continuous_disclosure.pdf
(20min delay)