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The FDA has already agreed that data collected from this trial could be used to support a future BLA, and UniQure said this morning they're moving ahead with th
by missedthecue 1y ago
The FDA has already agreed that data collected from this trial could be used to support a future BLA, and UniQure said this morning they're moving ahead with the BLA. In other words, uniQure likely will not need to run another trial before obtaining FDA approval for AMT-130.