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Stock impact report

Puma Biotechnology Receives Results of CHMP Formal Decision for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Puma Biotechnology Inc (PBYI) 
Last puma biotechnology inc earnings: 2/20 04:07 pm Check Earnings Report
US:NYSE Investor Relations: pumabiotechnology.com/ir.html
Company Research Source: Business Wire
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer. On January 23, 2018, Puma announced that the CHMP had communicated a negative trend vote after meeting with the Company to discuss the MAA and that a negative trend vote meant it was unlikely that CHMP would provide a positive opinion related to the Company’s MAA at the formal CHMP meeting. The CHMP has noted that Puma may request a re-examination of the opinion and that a letter of intent to seek re-examination should be submitted within 15 days of acknowledgement of receipt of the final opinion package. Puma plans to submit this request in Show less Read more
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