Another nasal spray going to human trials, page-6

While I share mystification of others in regard to Viraleze and the TGA I would like t make a few points.

Viraleze, like Vivagel (Fleurstat, Betafem BV) is introduced via a mucous membrane and extensive clinical trials showed that astodrimer sodium was not absorbed into the bloodstream but was a potent antibacterial and antiviral (in fact the HIV virus was its first target).

While the Vivagel application was for a medical device, its approval did include an alteration to the poisons schedule to allow it to be sold in pharmacies. That alteration was for astodrimer sodium the active ingredient and quite obviously not the applicator nor the other ingredients.

Safety is always a major concern for the TGA and, given the huge amount of data available (including the hrealthy individuals trial) this can surely not be a matter of concern for them in regard to Viraleze. So why are they, taking so long? Are the Scripps trials the issue?

As readers will appreciate there were several trials of astodrimer sodium against various strains of the virus. One in Australia (funded by the Doherty Institute) and others by Scripps funded by SPL. The most significant of these was the in vivo trial conducted in accordance with WHO protocols using genetically engineered mice. The only ones we do not have are for Omnicron effectiveness, both in vitro and in vivo.

That Viraleze is a broad spectrum anti viral and safe seems to be beyond dispute.

Teddyward referred to the NZ approval as a "tick a box" self regulation affair, after which a distributor or SPL must stand behind the product with insurance and data, on the surface, this is not what the TGA are doing.

Few, if any, medicines are 100% effective, this is also true of prophylactics. As long as they commit no harm and have a probability of working they should be approved. I rest my case TGA.