Like kingtup mentioned on another thread Bauer (fda spokesman) seemed very negative towards mesoblast the whole meeting. I’ve never tuned into a ODAC meeting so that could just be the normal tone?
Couple questions if anyone has thoughts.. Is there a chance the fda will still want another trial pre approval to supply more data? Or will it most likely be we approve but please do another trial on adults afterwards?
I’m aware of the % of approvals when In favour of the advisory board
Cell Therapy News/Articles, page-5676
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