It's shattering hey
They're more than happy to use our product for eap or under compassionate use yet we've been issued a crl on issues which were addressed at ODAC and clearly accepted based on the 9 to 1.
I don't get it, why string msb along to do this? How is the disease ever going to be treated? Safety is not an issue so it should only make sense to approve the use with a post approval study.
Take care all
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