March 20, 2020 / 8:03 AM / 18 days ago

BRIEF-Oncology Venture Gets Feedback From On Approval Pathway For Dovitinib

March 20 (Reuters) - Oncology Venture A/S:

* REG-PRESS RELEASE ONCOLOGY VENTURE RECEIVES FEEDBACK FROM U.S. FDA ON POTENTIAL APPROVAL PATHWAY FOR DOVITINIB.

* RECEIVED FEEDBACK FROM ITS RECENT PRE-NDA MEETING WITH U.S. FDA REGARDING A POTENTIAL PATH TO APPROVAL FOR DOVITINIB, ONE OF ITS TOP PRIORITY PROGRAMS.

* FDA INDICATED THAT THEY WOULD ACCEPT NDA FILING IF SUBMITTED, AND PROVIDED ADDITIONAL GUIDANCE REGARDING SUBMISSION

* PLANS TO FILE A NEW DRUG APLICATION (NDA) FOR APPROVAL OF DOVITINIB FOR TREATMENT OF RCC LATE IN SECOND HALF OF 2020. Source text for Eikon: Further company coverage: (Gdansk Newsroom)

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