MSB to dispute FDA finding in Type A meeting, page-5

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    Thing is, my suspicion is that it will be considered independently, because its used for a different indication. Hence the accelerated approval pathway in this particular indication for Peds Steroid Refractory Acute GVHD.

    @otherperspective posted something very good about this today. Which I will repost here -

    https://hotcopper.com.au/data/attachments/2524/2524605-1f8fefddbed6498a6f9713d0fb9ffd52.jpg

 
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