Not APPY: Venaxis stock plunges on new FDA no for appendicitis test
This article was originally published in Clinica
Venaxis’s share price plummeted 73% after the US FDA scotched hopes of the company getting 510(k) clearance for its APPY1 appendicitis test. The agency said the test was not substantially equivalent to a predicate device, which is needed in order to get regulatory clearance. The firm’s stock closed at $0.55 on 29 January, the day it reported the news, down from $2.04 the day before.
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