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Replies to post #232148 on NorthWest Biotherapeutics Inc (NWBO)
sentiment_stocks
06/07/19 4:16 PM
#232157 RE: exwannabe #232148
Piqray is the first new drug application (NDA) for a new molecular entity approved under the Real-Time Oncology Review (RTOR) pilot program, which permits the FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, allowing the review team to begin their review and communicate with the applicant earlier.
Up until last Friday, FDA had only approved supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAS) under the RTOR pilot. FDA had never even publicly said that it was expanding the RTOR pilot to NDAs until announcing that Piqray’s NDA had been approved.