From what I've seen, the TGA is more conservative than some other international drug regulatory agencies. So I wouldn't be surprised that they would only approve Viraleze with its current supporting data if they make only the most broad and general claims, perhaps about it providing a moisture layer, and with little or no reference to killing viruses. So even if it gets approval, the market for it could be limitjed. I think even wording like "barrier" or "protects" or "virucidal" imply some sort of efficacy, and they just don't have the data to support that.
That's why I've always thought that SPL needed to do human trials to seriously develop Viraleze, and why I asked questions at the 2020 and 2021 AGM about whether they were planning to do this. I missed the Q&A part of the last AGM, so didn't hear if my question was answered by Jackie, but this is what Investor Relations replied to me when I emailed them the same question afterwards:
"Yes, Starpharma is considering potential clinical studies in terms of post-market studies of VIRALEZE™. They do involve the end points you’ve identified, including use of positive COVID cases to investigate viral load, severity of symptoms, and other end points.
We do have extensive efficacy data of SARS-CoV-2 in laboratory studies and at therapeutic concentrations. (i.e., the same concentration that is in VIRALEZE™), and we note that there are other antiviral nasal sprays that have similar mechanisms of action that have also been registered with similar data."
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