Barclays Maintains an 'Overweight' on St. Jude Medical (STJ); CardioMEMS Preview & Guidebook
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Price: $80.82 --0%
Rating Summary:
3 Buy, 21 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 12 | Down: 15 | New: 40
Rating Summary:
3 Buy, 21 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 12 | Down: 15 | New: 40
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Barclays maintains an 'Overweight' on St. Jude Medical (NYSE: STJ) price target of $51.00.
Barclays analyst says, "On December 8, 2011, the FDA will hold a panel to vote on the premarket approval for the CardioMEMS Champion HF Monitoring System...While we ultimately expect approval, we think there will be noise at panel around potential bias. 1) FDA is concerned that HF recommendations by the sponsor and National PIs for individual subjects in the Treatment arm only may bias the study results because these efforts may minimize hospitalization for Treatment group subjects without a comparable effort for Control group subjects. 2) Additionally, the level of involvement of the sponsor during the clinical trial would not be duplicated in a post-market environment."
"We think these topics will be raised and the discussion will be centered around whether potential bias ultimately skewed the benefit in the treatment arm enough to negate confidence around the result. In our view, while the treatment recommendations may have had a small impact, we believe the magnitude of the benefit will outweigh these concerns and note that in the real world, the company may ultimately be involved in the management of patients through alerts and recommendations. Net-net we expect a recommendation for approval from the panel. We are modeling a late 1Q12 launch and revenue of $31 million and $54 million in 2012 and 2013, respectively."
For an analyst ratings summary and ratings history on St. Jude Medical click here. For more ratings news on St. Jude Medical click here.
Shares of St. Jude Medical closed at $36.95 yesterday.
Barclays analyst says, "On December 8, 2011, the FDA will hold a panel to vote on the premarket approval for the CardioMEMS Champion HF Monitoring System...While we ultimately expect approval, we think there will be noise at panel around potential bias. 1) FDA is concerned that HF recommendations by the sponsor and National PIs for individual subjects in the Treatment arm only may bias the study results because these efforts may minimize hospitalization for Treatment group subjects without a comparable effort for Control group subjects. 2) Additionally, the level of involvement of the sponsor during the clinical trial would not be duplicated in a post-market environment."
"We think these topics will be raised and the discussion will be centered around whether potential bias ultimately skewed the benefit in the treatment arm enough to negate confidence around the result. In our view, while the treatment recommendations may have had a small impact, we believe the magnitude of the benefit will outweigh these concerns and note that in the real world, the company may ultimately be involved in the management of patients through alerts and recommendations. Net-net we expect a recommendation for approval from the panel. We are modeling a late 1Q12 launch and revenue of $31 million and $54 million in 2012 and 2013, respectively."
For an analyst ratings summary and ratings history on St. Jude Medical click here. For more ratings news on St. Jude Medical click here.
Shares of St. Jude Medical closed at $36.95 yesterday.
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