| 2019-03-19 18:51:57|
SIEN 18:51 03/19 03/19/19
Sientra implied costs to gain FDA compliance negligible, says Wells Fargo
Wells Fargo analyst David Maris kept his Market Perform rating and $9 price target on Sientra after the company disclosed an FDA warning letter for failure to comply with the post-approval study requirements for its silicone gel breast implants. The analyst notes that he spoke with the management, and they believe that the FDA is targeting a patient follow-up rate of 65% at the end of 10 years after the study vs. the company's current 61% at year 3. Maris adds that given about 5K patients in the study with $100-$200 implied cost per patient, the required incremental cost to address FDA concerns is "negligible" relative to the company's current operating expenses.