So after all this, that is your big comeback?
As you are well aware that was not the key point I was making. Rather, it was an aside on the ethics alone re the lack of alternatives with aGVHD for all patients not just children, and the comparative strictness being applied that's appropriate for pharmaceutical drugs which are potentially very damaging. I personally find double blind trials in that context - of aGVHD mind - to be really onerous and condemning a significant amount of patients to death. But that's just me.
The key point I was making and still make, is MSB is being held back from its first approval in this case the children with aGVHD. It's perverse. SI. has been rightly preoccupied with saving lives and you know that too.
The Gold standard? Yes efficacy must be demonstrated but the FDA has been all over the place with this compared to the unmet and urgent need to save lives, and harmlessness to the patients with the treatment, and you know it. What they could do is look at the data, and make intelligent decisions with it. But like the emotional children that they surely are, they just don't wanna.
You have descended into mudslinging and technocratic level exchange parroting FDA requirements that are greatly lacking in this context.
And you have lacked a sense of proportion and practicality in this discussion and been damaging in your attacks on the CEO.
Surely you can see that. You were grandiose in your statements so it's incumbent on you to find an enemy, in this case you chose the CEO and not the enemy within, being your ego, and not making the FDA accountable which is also the more rational response.
I expect better from you and trust that somehow you will find a way to recognise how needlessly damaging your latest contributions have been.
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