Announcement 17/8/21. Another positive study related to Viraleze. This one was focussed on safety and they found that it was indeed safe. They measured safety from two different angles:

• First, they counted the number of "adverse events" (AEs), which can be anything unpleasant. They found no notable or serious AEs, although they didn't say what exactly classifies in these categories, and they also found no AEs that led to a patient needing to leave the study, which would likely be a major issue. They do give some information about the mild AEs that occurred --- discomfort or congestion in the nose, nose bleeds and headaches --- but they all occurred at similar rates in the placebo control group, so these outcomes are likely just noise.
• Secondly, they measured the amount of the active ingredient found in the patients' blood plasma, and didn't find any. This is good since you don't want any foreign bodies in your blood if you can help it. This helps avoid things like immune responses. Additionally, although they didn't mention this, since they're also developing their dendrimer technology to treat cancer it's good to know that the Viraleze up your nose shouldn't interfere with any of their cancer drugs you might be taking.

Another positive point from the study is that compliance was extremely high (99.9% for the Viraleze and 100% for the placebo). According to the numbers they quote for people in the trial and how often they they used it, 99.9% means that out of the 1680 intended doses, only 2 were missed. This indicates that it's not hugely uncomfortable or inconvenient to use the spray, which bodes well for people using it properly if they buy it and then continuing to buy more.

So it's all looking good, but I'm still waiting to get some real sales numbers for Viraleze (although I may have missed them somewhere).

(Disc: held)

The ASX announcement on 5/7/21 is a bit disappointing. Apparently the TGA had fined them $93,240 for advertising their Viraleze to Australians when the TGA hasn't approved it for sale here. It seems that this is a result of the websites containing the advertising being accessible from Australian IP addresses. The company probably should have been on top of this issue before being fined, but they say that they fixed the problem straightaway and I just checked the website viraleze.co --- sure enough it has almost no information now.

However, they do raise an interesting point: how can they keep Australian shareholders up to date on their new products without breaching the Therapeutic Goods Act? They say that they will ``work closely with the TGA'' to sort it out. Surely other biotechs have come across this problem though, so I hope the TGA can give them some good guidance, and that this is the last we hear about these penalties.

(Disc: held)