Ruxolitinib passed FDA approval on poorer single arm study results than Ryconcil, page-42

Not sure if this has already been posted but I found an interesting petition against Ryoncil/remestemcel-L on regulations.gov from 20/07/20.

https://www.regulations.gov/document?D=FDA-2020-P-1689-0001

While it is titled a "Citizens Petition" it seems to be written on behalf of Jakafi (ruxolitinib), possibly trying to protect their market share. I found it interesting that it reads very similar to the FDA briefing document and raises many of the same issues. I wonder if it has influenced their thinking? It may also be that the FDA is looking to the panel to help them work through these objections.

What is also interesting is the omissions. So far I haven't found any reference to the improvements made since the Osiris trials and the safe use of Temcell in Japan (will probably need to study it again though). Obviously if their motivation is to protect their commercial interests then there will be a bias in what they present. Presumably the FDA would be aware of this and take into account Mesoblast's presentation, which will provide some balance.

I decided to post this because it occurred to me that some people have interpreted the FDA briefing as raising their own (FDA) concerns. However, if they are also raising the concerns of a competitor and therefore looking for the panel to help them to work through them, then for me it takes some of the heat out of their comments. It also puts the briefing paper in a different light.