it would have been far more likely to have been approved if it...

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chrisnj

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09/03/22

12:25

Post #: 60083936
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Originally posted by BobF: ↑

This still all sounds to me like SPL presumed that TGA would be forced to allow it to register Viraleze as a device - without human trials - then market it as if it were a medicine, or at least described in its marketing as being as close to being one as it could be positioned without actually calling itself one. The difference between a spray up the nose being a medical device or a medicine seems to all come down to whether it enters the bloodstream or not. While it appears not to do so, it would have been far more likely to have been approved if it also had full human testing to back up its lack of toxicity or unanticipated side effects. (And yes, that is clearly possible to do.) That would have cost money, and SPL did not want to spend the money there. It has really tried to get the best of both worlds, at negligible cost, but with TGA it has simply not worked. SPL has been too clever by half, and TGA is not the only place this has proven to be its downfall. SPL appears to have forgotten that TGA (and other national agencies with similar responsibilities) is the regulator and only has to satisfy itself that it is safe. The responsibility of the TGA is to ensure the safety of the public, who would generally not have a clue that there is even a difference between a medical device and a medicine. They go by the description on the package based on the assumption that if it was not true then surely it would not be allowed to be sold. Is that approach by SPL's management negligence, tricky wishful thinking, or cynical manipulation of the regulators using their own regulations? I think all three.

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it would have been far more likely to have been approved if it also had full human testing to back up its lack of toxicity or unanticipated side effects. (And yes, that is clearly possible to do.) That would have cost money, and SPL did not want to spend the money there.

@BobF that's what the trials they conducted in Perth last year were for.

They haven't done human trials for efficacy because they are simply too clever by half.

SPL Price at posting: 81.3¢ Sentiment: Hold Disclosure: Held
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