Rae915, thanks for the questions.
Your statements about the history of the trials and TGA's stated view are substantially correct. Just note that TGA did not "approve sale overseas"; the agency did provide us with an export permit (on the basis that the product is a quality and safe product) and this has allowed us to provide clinical trial stock to overseas trial sites over the last few years and to export the product for sale to any country where local regulations allow the product to be sold, such as Singapore.
As to our plans for future common cold clinical trials, as I have stated publicly, we are considering trial designs that use objective primary endpoints and do not rely on subjective patient reported symptoms. Also, because we are convinced that Nasodine works extremely well if used at the first signs of a cold and that's how most people would use it, we are looking at trial designs that reflect that reality.
We are still committed to proving that Nasodine is an effective treatment for the common cold, and while we consider the best pathway forward on that front, we are making the product available as a nasal antiseptic/disinfectant to generate sales and build HCP support wherever we can.
Regards
PM
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