Maybe a buy out by a large US Pharma company is our best bet for approval. Would not be surprised if there was an offer in the making, the business world can be cruel.
Asking for a placebo to be used for kids is rough, really rough.
Doing the test on adults and then using that data, when the application is for GvHD in kids, seems pointless.
FDA have blood on their hands. The request for more data should have been post approval. A simple death rate of treated vs untreated kids in America would have confirmed what they needed.
Land of the free has just chained more kids to death.
I'm calling a big pharma buy out before approval.
Maybe a buy out by a large US Pharma company is our best bet for...
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