You don't reply to my substantive points. Calling them ravings...

You don't reply to my substantive points. Calling them ravings is pretty poor since others take a similar position and you still refuse to refer to the article in Endpoints because you're dead keen on prosecuting SI, expressed slightly differently.

The comparative inadequacy of the FDA doesn't seem to bother you at all.

The condition of the aGVHD patients post all the exhaustive treatments they've been given has the key to the problem, while ironically you and the FDA bang on about uniformity.

They are the weakest of the weak plus their condition is not uniform precisely because of the variety of treatments and the interactions. The fact that SI has gamely gone on with the FDA to try to educate them with the appeal in this impaired situation shows that he, is keen on saving lives.

The fact that there is indeed a baseline of the 85% mortality rate should give you cause for pause and reflect again on the possibility of AA, as foreshadowed in the Endpoints article. You won't let that information in. You're very resistant to it. I can't understand why hubris is one possibility. As is the simple reality you're mad as hell and want revenge.

suggests the FDA bureaucrats must have a pretty good case when the say more (controlled) data are needed
The FDA are clearly making this up as they go along. They can make a case all they like the issue is reasonableness in ALL the circumstances. I'm interested in the prospects of AA, now you haven't convinced me why it's so unreasonable since the post approval data can be obtained from adults. It's a shame about the adult deaths post all the faffing around with those godawful treatments in particular steroids. But there's a lot of money in 'dem steroids.

IF, repeat IF MSB were able to treat the patients in a propylactic way, then the situation would be clearer. But that's not how it works. Destroy someone with 'life saving' treatments and then demand resurrection with the magic stem cells. Oh but you need to show how it works as well, we want to understand more...really? Is this about saving lives? It doesn't seem to be does it?

Arguably ryoncil remestemcel-L could be used as the first treatment and the steroids binned. This seems sensible into the future but you cannot see it that way. These are mad rantings to you but I can see a bit more laterally. Do try to get off your lofty position. The more you post the more entrenched your views are and they look like you're just face saving because you lost a lot of MONEY.

It's a pathetic sledging match and you refuse to believe anyone but your good self and others imbued with finer points of statistical analysis, have any shot at making a decent comment. You would be wrong.

It's all very well to proceed with an abundance of caution NOW, but blaming SI for your own judgements is a bit rich.

Your comments lack a sense of proportion but not much I or anyone else can do about that. Because you're determined to make yourself a victim of SI and that's what this is all about.

You are not taking the FDA to task on their own unreasonableness. I have set out the context for reasonableness several times above.

Just because you choose to ignore that as an issue doesn't make it less relevant.