MSB to dispute FDA finding in Type A meeting, page-777

From memory it was the first public submission to the ODAC meeting that the FDA released . I have no doubt that the FDA followed there letter and set the agenda of the meeting . They may have even convened the meeting in response to these issues.

We should not forget SI put forward a very good argument that won the view of the ODAC panel 9-1 and Novartis.

I believe Novartis went in to protect Jakafi and came out knowing that Mesoblast had the product and ability to push them out of adult GVHD and possibly many other indications. It is not to hard to see how SI could design a randomized trial and show far better efficacy and SAFETY .

Let's look at there COVID ARDS statement on safty

"Ruxolitinib was generally well-tolerated, and a comprehensive analysis including safety data is ongoing1. The results of RUXCOVID do not affect any ongoing trials for ruxolitinib in non-COVID-19 diseases"

This is not a particularly great statement as it down plays the importance of safty. We can take from the term "generally " that it was not well-tolerated. Then in the same sentence "comprehensive analysis including safety data is ongoing" Then the last sentence ,well we weren't that bad , the death toll isn't much smaller in the control.
Now what benefit would a partnership give Novartis?
Protection from sudden revenue drop. They may suffer considerable revenue loss from GVHD but should be able to pick up ARDS if not EU COVID ARDS . They also pick up 50% of other indications so not so much a big deal if Jakafi is displaced.