2023 The Final Countdown, page-3322

but I trust a biased first account witness over a non witness, as most investors do.

And like Lopez says who you gunna believe?

Krause who it seemed expected a BLA and was part of a team involved in preparing for it and didn't get it and speaks in conferences under the disclaimer of forward looking statements and has possibly some reason to be a tad embarrassed or some random guy on the internet (who isn't really that random anymore as if happens - randomness is without pattern - as he's been around on the forum and posted on the forum for some time and predicted the CRL (contrary to Krause) and the reasons for the CRL (insufficient data) before it was actually announced.

So how did random guy manage to do that? Crazy dumb luck against Krause dashed bad luck? But the arguments are still on the forum.

I have NEVER recommended appeals in or faith in claimed authority. That's why qualifications don't count. Darwin didn't have a biology degree - Mendel didn't have a genetics degree - they were amateur enthusiasts.

But when the results are there, when they are demonstrated, when the process of reasoning is there (pfeifer has walked some of your through them making the arguments shorter and clearer) when the timeline is still there, that is not a claim to knowledge,that is not an argument for authority - its a demonstration of knowledge no?

SAFETY and EFFICACY are required. MSB has established safety.

Had you establised efficacy you'd have a BLA right now. The bottom line is that you have not.

The bottom line is not that the cells work - the bottom line is that you haven't shown that the there are certain things, certain potency factors (like TNFR1 levels and inhibition of IL2Ra levels) that ALONE are sufficient to ensure that the cells work. That the actually bottom line - MSB has not establised that yet.

Not established the validity of the potency assay because you are needed trial results to do that and the trial results were confounded.

Not established efficacy because the FDA doesn't know that its going to be the same product if you just use the potency assay you have - so they aren't even allowing that.

Bottom line is the cells alone (are too variable and too unpredictable and so don't reliably work) SO you have to actually understand more about the cells to understand why they work sometimes and not others. So you can get the types of cells that do work separated from the ones that don't work. So the poor sick little kiddies parents don't get charged huge amounts of dollars for something that is a dud.