Trex Wind Down Inc (fka TMBRQ)

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A Fast Track designation allows for more frequent meetings and written communication from the FDA to discuss a drug's development plan and the design of proposed clinical trials to ensure collection of appropriate data needed to support drug approval. Fast Track designation also allows FDA to conduct a rolling review of an NDA or BLA, which means that a drug company can submit completed sections of its application to FDA for review, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. A drug that receives Fast Track designation may also be eligible for Accelerated Approval and Priority Review.