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Re: go seek post# 15594

Sunday, 10/06/2013 6:55:34 AM

Sunday, October 06, 2013 6:55:34 AM

Post# of 448129
Hi Bruce..

You, Dew and I have a lot of history. I have the upmost respect for Dew and think he is one of the most knowledgeable, and wise people I know in biotechs..That said, none of us get it right all the time..

DD... "The real question is what the FDA will do. They don't have to follow the panel."...

JL..This is an absolute fact..This could play out either positively or negatively..IMO More likely to help AMRN than to impede them..

DD..."A lot of cardiologists no longer believe that surrogate endpoints (such as triglycerides, HDL, etc.) predict risk of CV events."

JL..The concern as Dew mentions is that the FDA may want to hold out for the CarFax (REDUCE-IT results)...The realities here is that talk is cheap..These cardiologist talk about "Keeping it Real" with outcomes, but in the clinic is a different story...It's all about the lab values...How else could we have the enormous statin trade...Malpractice lawyers call the shots in clinical medicine, and they focus on lab values..so if you are over 50 and go in for an annual bet your money the doctor will be running a lipid profile. That seems to be the FDA attitude also..

So no big argument with Dew...just think considering the SPA, and the once modification (REDUCE-IT) combined with V's safety profile, most likely the FDA grants the sNDA in Dec...

":>) JL
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