In an update,
the European Medicines Agency’s advisory group CHMP states that it has
started a rolling review of data on Gilead Sciences’ (NASDAQ:GILD) remdesivir for COVID-19. It finished the first cycle of the rolling review on May 15 and has requested additional data.
The next step in the process is the submission of
said data together with an application for conditional approval. The
company has yet to file the application but is expected to do so
shortly.
CHMP will assess it “under a timeline which will
be reduced to the absolute minimum to still allow a thorough evaluation
of the benefits and risks.”
https://seekingalpha.com/news/3578578-gilead-not-quite-remdesivir-nod-in-europe
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