Yes its absolute lunacy
Viraleze traps the virus in the nasal passage, lets say for argument sake its mechanism of action may only trap a small proportion - if so it has to be as effective as a mask, there is your equivalence regarding protection.
Its a device not a medicine, and i suspect it has caught the TGA in no-mans land with how to deal with it. That inflexibility may be the result of inflexible legislation - if so it should be rectified quickly by amendments to regulations by Parliament.
Interestingly Jackie sees no need for a trial in order to get it approved, but is prepared to consider a trial to assess its possible role in treatment (see Q&A - my take of what she has said).
She also stated that Regulatory Bodies work to their own timeframe, so dont hassel them.
A disgrace - approve or reject Viraleze now.
Marketing of VIRALEZE ™ in Vietnam, page-93
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