Establishment Labs shares are trading higher after the company announced the Center for Devices and Radiological Health completed its review of the company's premarket approval application for Motiva Implants and has issued a letter to the company instructing that the application is approvable subject to an acceptable FDA inspection of the Company's manufacturing facilities.
Portfolio Pulse from Benzinga Newsdesk
Establishment Labs shares are trading higher following the announcement that the Center for Devices and Radiological Health has completed its review of the company's premarket approval application for Motiva Implants. The application is deemed approvable pending an acceptable FDA inspection of the company's manufacturing facilities.
June 05, 2024 | 1:46 pm
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Establishment Labs shares are trading higher after the Center for Devices and Radiological Health completed its review of the company's premarket approval application for Motiva Implants. The application is approvable pending an acceptable FDA inspection of the company's manufacturing facilities.
The news that the premarket approval application for Motiva Implants is deemed approvable is a significant positive development for Establishment Labs. This approval, pending an FDA inspection, suggests a high likelihood of the product entering the market, which is likely driving the stock price higher.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100