Thanks gsmi086,
Its confusing with the different products and different approvals required in different places.
And maybe I'm confused.
But I read the 2013 annual report as saying that they had re-applied (after the first rejection) for OTC status for Sonosentry (the stand alone updated Wheezeometer) in the 4th quarter FY 2013.
Lets say for the sake of argument June 2013.
120 days have passed and so in theory a determination should have been made.
What was the outcome? Was it abandoned, rejected, approved, still under review, changed, time extension granted etc?
Its a simple question (unless I have missed an update - or have misunderstood what they are applying for) that should have a simple answer.
The lack of an answer to this question is not helping the sp imo.
Why?
Because if Sonosentry is deemed safe and effective to be used OTC (without medical supervision and without prescription) this bodes very well for getting Airsonea up as OTC.
If Sonosentry is rejected as OTC this suggests that getting Airsonea up as OTC just got a lot harder.
OTC is important because of sales numbers. Probably say a factor of 10 or more at a wild guess.
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