BD Remains Confident About LUTONIX DCB Despite FDA Letter
Zacks Investment Research | Mar 24, 2019 10:49PM ET
Becton, Dickinson and Company (NYSE:BDX) , popularly known as BD, announced that it has received a ‘warning’ letter from the FDA on Mar 15, 2019, regarding the increased long-term mortality of its LUTONIX drug-coated balloon (“DCB”). Notably, the FDA’s concern follows a solid preliminary analysis of long-term data of the LUTONIX DCB.
BD’s flagship LUTONIX DCB is a paclitaxel-coated device that is used to treat peripheral arterial disease in the femoropopliteal artery. Following the news release, the share price of BD inched down 1.8% yesterday. The stock has a Zacks Rank #3 (Hold).
Three Major Factors Supporting BD
Per the recent press release issued by BD, it seems that the company is still optimistic about the LUTONIX DCB. Here’s Why:
Favorable Pre-clinical and Clinical data
Investors should notice that BD has issued a statement indicating the “robustness of its pre-clinical and clinical data” of LUTONIX DCB. Management at BD claims to have evidence from seven separate studies that successfully demonstrated the safety and efficacy of these products.
This apart, BD has analyzed and reviewed all available data about the LUTONIX DCB over the past several months, all of which had favorable outcomes.
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