Not so good.....
At the current time it appears that the FDA review team will not agree to accelerated approval. However, the definitive outcome of the Type A
meeting will not be known until Mesoblast receives the formal minutes which are expected within 30 days of the meeting. If
the current review team does not agree to accelerated approval, Mesoblast will request a further Type A meeting to initiate
the well-established FDA dispute resolution pathway.
Not so good.....At the current time it appears that the FDA...
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