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Correvio slips after FDA staffers say benefits of heart drug do not outweigh risks

Dec 6 (Reuters) - Staffers at the U.S. Food and Drug Administration reviewing Correvio Pharma Corp's heart drug said on Friday it did not believe that the benefits offered by the therapy outweighed its risks, sending the company's shares down 11%.

The drug, Brinavess, which has been approved in several other counties including Europe and Canada, aims to correct erratic heart rhythm due to a condition known as atrial fibrillation or AFib.

A panel of independent experts to the FDA is set to convene on Tuesday and vote on the approval of the drug.

The FDA, which is slated to announce its final decision by Dec. 24, is not mandated to follow the recommendation of the panel, but generally does. (Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta)
https://finance.yahoo.com/news/correvio-slips-fda-staffers-b…
 
aus der Diskussion: CORV (Mkap $95 M) FDA Entscheidung in Dezember /ADCOM eventuell in November
Autor (Datum des Eintrages): Palawanobi  (06.12.19 14:55:41)
Beitrag: 36 von 212 (ID:62096810)
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