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HinduKush

08/26/20 7:55 PM

#292881 RE: L0tsaluck2000 #292862

Lotsaluck,
Agreed and well put, the time of 1 year prior to curve separation is an average for the entire cohort in each randomization, it does little to predict an individual's fate. Anymore than wearing a seat belt over a life time of driving..it might save you in 1 year, or it might save you the next day...There is also no difference between cancer and MI they will both kill you under the right circumstances. The differentitaion is flawed. I can show you stage IV heart failure patients or cardiogenic shock patients after a myocardial infarction, that have worse prognoses than a cancer patient with metastases.

Your logic is flawed. Every month of delay means one more month of people not receiving the benefits of V whether in the first month like is the case for some cancer patients or in the 24th month for meds like V that have cumulative benefits that grow over time. If it takes V 24 months to work, there will be a cohort in 24 months that will be impacted because their initiation of V was postponed a month.


Replying to sts:

Just my personal opinion, but if I was AMRN I would be intentionally slow walking the EMA process so I don't get formal approval before the appeal results are known - preserves maximum shareholder value. Whether it's immoral to delay people in the EU from getting V for a few extra months I sort of doubt it - we know the event rate curves didn't start to separate until somewhere between 1.5 and 2 yrs, so a few months may make no difference in outcomes. V isn't like an oncology drug where a delay of months could mean the diff between life and death.


HK