Oncolytics Biotech Inc T.ONC

Byondis' breast cancer drug fails to bloom as FDA denies app

[askretka]

https://www.fiercebiotech.com/biotech/fda-denies-approval-byondis-her-2-breast-cancer-treatment-citing-too-little-information

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Interesting because Pfizer just put a 43 Billion dollar bet on Seagen's ADC portfolio.  Cheers!!!!!!!!!!!

[Noteable]

Byondis B.V. (formerly Synthon Biopharmaceuticals) failed to provide PPS, ORR or evolving OS from a Phase 2 clinical trial prior to applying for a Phase 3 clinical trial, thus precluding the company from filing an accelerated approval before the company's completed their Phase 3 and filed the BLA. With this BLA, Byondis sought approval for its anti-HER2 antibody-drug conjugate (ADC)