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dr_lowenstein

11/13/13 8:51 PM

#77229 RE: Couch #77226

Not directly, if the FDA grants Priority Review, then possibly, but FT designation only provides

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
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BiotechInvestor90210

11/13/13 9:07 PM

#77234 RE: Couch #77226

Looking forward to the CC and earnings this week!
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conix

11/13/13 10:09 PM

#77241 RE: Couch #77226