Stop your panic JB
"You've got enough to get approval"
Does not mean the product will be approved,
Does not mean the product will be approved this BLA cycle either
It's declaritive and that's it..... you have enough evidence to get approved. Nothing more, nothing less.
Wasn't it the FDA who said no more trials until you sort something out, now the FDA have said you've got enough to get approval....
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Stop your panic JB"You've got enough to get approval"Does not...
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