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rafunrafun

09/05/19 10:32 AM

#212746 RE: Atom0aks #212741

Sir! You said "very, very small". All I am trying to do is get you to define YOUR numerical definition of such.

1?

10?

100?

1,000?

10,000?

Again, YOU said it, not I.

jessellivermore

09/05/19 10:58 AM

#212757 RE: Atom0aks #212741

Atom....

Please understand 4.8% of 4000 patients may not be a huge number 196 events..But Vascepa is not going to be restricted to 4000 patients...Say Vasepa is treating 80,000,000 patients (Vascepa's target. pop) then 4.8% is about 4 mil events...

Comprendez-vous???

":>) JL

Will Lar

09/05/19 1:49 PM

#212792 RE: Atom0aks #212741

Atom - Thanks for sharing the calculation. Interesting. The numbers used in the math are for the primary events which I thought are non-fatal events. The secondary events include cv death and others and the risk % is even smaller, e.g., 3.5%?

In any case, the % number is small, but multiply % with Vascepa target population size can yield hundred thousands patients in US, which easily beat any cancer patient population size. It's not necessarily death, but life threatening condition for all.

But I do remember seeing a chart of likelihood of getting a priority review vs. different therapeutic areas. Infectious disease is high on the chart, whereas chronic diseases like CV, Alzheimer's are on the low end. So the fact that Vascepa sNDA was granted a priority review is already a positive thing, even though the timeline is now more link a regular review.