No opinion here.
Medical devices (including IVD) have to be listed on the ARTG before they can be
- supplied in Australia
- imported into Australia
- exported from Australia
Therefore, this explains why Colostat isn't being sold into any markets as yet as RHY would not risk selling directly from France to the European Union etc without checking for quality control etc as they are the sponsor and would be the responsibly entity for any stuff ups.
These are the facts.
As sponsor and resposible for the product RHY is also regard as the manufacturer. even though they have Biotem packaging the blood test kit right up to the printing on the box etc.
Furthermore, I don't think RHY will be selling any blood test kits. I believe they will be relying on partners to sell it and RHY will receive a royalty (this is my opinion)
Like everything RHY
might (most likely) get to the market but will all depend on the partner(s), pricing and future obstacles with selling it.
How $40 -$50 was sprouted almost 2 years ago and is still being sprouted 2 years later with inflation and costs going through the roof has me dumb founded.
However "I was at a New years eve party a couple of years ago and a RHY insider told me that it would cost $10" (this is not my statement but someone else on this forum) - can't remember who.
Royalties in my opinion is what RHY is going for, not sales but let's wait and see.
With most submissions to the TGA there are are requests for further information and the clock stops there in relation to the time (days) taken to get approval. Thus far including public holidays it has been 157 days. The average stated by TGA is 141 days for IVDs.
The maximum is 255 days. So really it is anyone's guess when TGA will approve. Don't get me wrong, I have never said that it wouldn't get approved, I really discussed things that RHY has either failed or omitted in its announcements including negatives, not just all the positives of the blood test kit.
Now it also all depends on how many times the TGA goes back to RHY with questions or further information as to when they get TGA approval. It could go past 1 year (including Saturdays, Sundays and public holidays). Just saying.
So one can see it as "glass half empty or glass half full" which ever way you want to take it.
(20min delay)