MSB to dispute FDA finding in Type A meeting, page-982

LVAD trial wasn't ours. I'd be interested to know how treated patients are doing long term actually.

CHF: I read the criticism that endpoint should have been MACE and I see the point of that but results are still so good I don't know how this treatment can't be approved. Another trial would enrol quicker but I can't see how it could be stopped for OE because of MOA of cells setting off a healing cascade where treated group goes on to improve relative to placebo.

CBP was complex and I had trouble with this. I'd have liked more information but the trial was about pain and the outcome was achieved and it could be approved on the basis of that. I felt this candidate, like the company itself, is a lot more than it seems.

ARDS: I was uneasy about the primary endpoint from the start. It's well known to be a courageous one but I don't see how any other could be chosen in the emotive climate of a pandemic. There were smart scientific posters here who kept the focus intensely on the primary endpoint but if you look at the literature and see what insurers are paying for, it's bad survival. Before our trial was influenced, I was expecting significant efficacy but I was thinking that would be clearly shown after months, even a year. That's why I decided to bang on endlessly about fibrosis. All may not be lost here.

I see what's going on in the world as much bigger than the FDA and big pharma. A revolution is going on, a great leap forward in other technology such as AI, truths emerging about this world that are psychologically difficult to accept. I this as a restructuring of society for the better but I only have one clue for that.

Perhaps Ryoncil is being held to unusual scrutiny precisely because the FDA hasn't had a high bar. A line needs to be drawn to define the end of one era and the beginning of another. I sure HOPE so because it's unthinkable not to approve this candidate, but like I've said, none of us knows the future and we can only speculate.