Investors in Clovis Oncology (NASDAQ: CLVS ) received some welcome good news when the company announced that its EGFR blocker CO-1686 received FDA's coveted breakthrough designation. This gives companies a speedier FDA review and easier access to regulators as they work to get individual drugs approved. CO-1686 targets a subset of non-small cell lung cancer patients -- a subset with no approved treatments thus far, according to Clovis.
While the news was good, it's important for investors not to overreach -- this is a drug still in pretty early clinical trials, as Clovis is currently beginning enrollment in two phase 2 expansion studies, with a New Drug Application (NDA) hopefully in the offing by mid-2015.
In the video below, from Tuesday's Market Checkup, The Motley Fool's health care-focused investing show, health care analysts Michael Douglass and David Williamson discuss this news and what it means for Clovis investors.
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