Ann: Mesoblast Update on COVID-19 ARDS Trial, page-965

Many thanks for the kind words@Wilba32 @Kerrybrad@reginaldp @Nazgouhl @col69 @ddwn @lukewarmtin @tennis58

Yes, my bad. I do recall that SI mentioned we flew through the first interim analysis. Gap might have started to narrow after that. That actually fits with my theory better because of when the hype started around the Recovery trial. It wasn't just Dex but other corticosteroids and that was the catalyst, according to the Nature article I referred to, for doctors to return to what they knew.

I don't have a science background and am no expert on trials, but I asked a friend why there wasn't stipulation about when to use the cells. He said perhaps because doctors would be less likely to use them. I was worried about this exact thing, the basic MOA of our cells that respond to signals of high inflammation, but at the start of the pandemic the narrative was finally in our favour with the hype over the China study and that getting quickly published. It suddenly changed with the Recovery Trial.

Steroids could also explain any 'batch consistency' issue. The tapering off steroids and the possibility that in some patients the steroids could have dampened inflammation to an extent, which could explain any inconsistency in response.

I don't know if we have enough data from the earlier part of the trial for an EUA but surely Novartis will be smart enough to look at the why, when and how, not just the what. I doubt if steroids do much for fibrosis in ARDS because if they did, there wouldn't be 25 years of debate as to whether to use them. We could still have a win here but I think it takes time to show up.

I said a couple of years ago, If the science was bad things would get ugly and if the science was good things would get ugly. I think the science is really good but we have to make our own minds up. I've long been prepared for ugliness. I can't say what the SP is going to do but it's important to read every ann carefully and think about it.