Some comments on ANCHOR at the conference... Just got hold of the transcript!
"We are conducting a cardiovascular outcome study. We're in the first quarter that we were over 4,000 patients enrolled. This was the gateway towards allowing us to submit and have accepted the FDA for the ANCHOR indications in conjunction with that whole process. There has been no suggestion from FDA that they are going to change in anyway the requirements for getting approval for the ANCHOR indication, the approval requirements were up for the reduce study to be substantially underway.
We have completed that. We are continuing to enroll aggressively in that study and relative to the ANCHOR indication we believe we're very much on track for approval on the PDUFA date of December 20th. We have a experienced management team that we've continued to expand here for the commercial life of Amarin and we recently completed a dosing and a combination trial which will have results to report in this near future. Just for perspective, the field look at lipid management has historically been focused a lot on particular stand LDL management with nice and rates of the LDL.
Having said that, despite those therapies There is residual risk, cardiovascular risk and as been shown through various studies that managing other lipid parameters can have an improvement in cardiovascular particularly for patients with elevated triglycerides. Drugs that have been out there to treat triglycerides in the past have had the effect of lower triglyceride but increasing bad cholesterol while doing which isn't we believe an ideal effect."
http://www.earningsimpact.com/Trans...--Jefferies-2013-Global-Healthcare-Conference
"We are conducting a cardiovascular outcome study. We're in the first quarter that we were over 4,000 patients enrolled. This was the gateway towards allowing us to submit and have accepted the FDA for the ANCHOR indications in conjunction with that whole process. There has been no suggestion from FDA that they are going to change in anyway the requirements for getting approval for the ANCHOR indication, the approval requirements were up for the reduce study to be substantially underway.
We have completed that. We are continuing to enroll aggressively in that study and relative to the ANCHOR indication we believe we're very much on track for approval on the PDUFA date of December 20th. We have a experienced management team that we've continued to expand here for the commercial life of Amarin and we recently completed a dosing and a combination trial which will have results to report in this near future. Just for perspective, the field look at lipid management has historically been focused a lot on particular stand LDL management with nice and rates of the LDL.
Having said that, despite those therapies There is residual risk, cardiovascular risk and as been shown through various studies that managing other lipid parameters can have an improvement in cardiovascular particularly for patients with elevated triglycerides. Drugs that have been out there to treat triglycerides in the past have had the effect of lower triglyceride but increasing bad cholesterol while doing which isn't we believe an ideal effect."
http://www.earningsimpact.com/Trans...--Jefferies-2013-Global-Healthcare-Conference