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11:34
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Originally posted by bedger:
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I do the same thing stockrock. These writings of late are by far the most intelligent seen on MSB threads - its a shame the good stuff only comes out when we are in trouble. I am under no illusions about the type A meeting and enjoyed your different perspectives. Whilst we of course have many other read-outs pending, for GvHD longs best hopes are indeed an under 12 approval for unmet needs, with a conditional RCT in adults. MSB have to tread subtly and carefully. Guns blazing with threats of pulling GvHD is not going to help, but subtly suggesting a massive GvHD trial is not really a good investment with the small revenues by comparison to other applications might not be a bad tactic.
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Good post @Berger - lucky for us we have SI as our CEO, he can continue to have a calm discussion with the FDA.
(20min delay)