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Monday, January 13, 2020 4:50:27 PM
Hamoa...
This post of yours is beautifully written and is very compelling...An impressive feat..I only hope Judge DU is half as wise as you are and I hope you are prescient in this case..
The story of Vascepa is a great one and one of the reason why it is a great story is because things were never obvious..Certainly not obvious to the cardiologists who attended the 2018 annual scientific meeting of the AHA..Prior to Dr. Bhatt's presentation of the RI data..The cardiologists were polled on their smart phones as to whether they were would prescribe Vascepa to their patients at risk for CVD and less than 10% said they would..After the presentation the number who said they would jumped to over 90 %...There was a standing ovation after the presentation...Something very rare in clinical presentations..
The FDA did not think the the results of R-I were a foregone conclusion and even went to the extreme of reneging on an SPA...I'm not aware of FDA ever doing that before...FDA did not think V would lower CVD event risk...and insisted on a CVOT (cardio vascular outcomes trial)...A trial that ran eight years and never once did the FDA say "stop the trial"..its obvious....
Thank you for writing one of the best posts I have seen in more than 10 years...
":>) JL
This post of yours is beautifully written and is very compelling...An impressive feat..I only hope Judge DU is half as wise as you are and I hope you are prescient in this case..
The story of Vascepa is a great one and one of the reason why it is a great story is because things were never obvious..Certainly not obvious to the cardiologists who attended the 2018 annual scientific meeting of the AHA..Prior to Dr. Bhatt's presentation of the RI data..The cardiologists were polled on their smart phones as to whether they were would prescribe Vascepa to their patients at risk for CVD and less than 10% said they would..After the presentation the number who said they would jumped to over 90 %...There was a standing ovation after the presentation...Something very rare in clinical presentations..
The FDA did not think the the results of R-I were a foregone conclusion and even went to the extreme of reneging on an SPA...I'm not aware of FDA ever doing that before...FDA did not think V would lower CVD event risk...and insisted on a CVOT (cardio vascular outcomes trial)...A trial that ran eight years and never once did the FDA say "stop the trial"..its obvious....
Thank you for writing one of the best posts I have seen in more than 10 years...
":>) JL
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