The power of big pharma conversation is valid but I believe due to the small patient population and the unmet need of pediatric GVHD this treatment will be approved.
The use of stems in the future is inevitable and they know it. This is the perfect introduction to ease the blow, letting pharma companies know that this is happening whether they like it or not.
I also like that the FDA asked for further, more specific CHF data to give them the opportunity to approve a smaller patient population without too much kickback.
Just edging the door open ever so slightly to reduce the stigma of stems for the world to see this is the future and there’s plenty more to come.
The power of big pharma conversation is valid but I believe due...
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