Ann: S&P DJI Announces March 2022 Quarterly Rebalance, page-67

SI told shareholders that the Covid trial "flew through" interim assessments before it was stopped because it failed a futility test. SI told shareholders that he expected approval for treatment of aGVHD before the FDA said "no". SI assured shareholders that the Novartis agreement would be ratified in "a few weeks" but they eventually pulled the plug on the deal 12 months later. SI said he didn't know why, but clearly it would have been spelled out in the reason for termination.

So whatever SI "believes" should be taken with a good helping of caution. Particularly when the FDA have expressed very clear reservations and said what they think is required, and SI chooses to ignore it and go a different way. All your concerns are valid IMO.