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bfost

11/29/19 11:12 PM

#230901 RE: jomama9231 #230872

Jomamma - totally understand your point. I wouldn't want to be at risk for an MI or stroke and be taking an MTNB drug either when I know Vascepa gave a 25% benefit with a p value of 7 0's. On the other hand there's got to be ways to identify new drugs which may be beneficial in a similar class. Lipitor and Crestor appear to be better then their early statin counterparts. Although I'd be very surprise to see MTNB, Acasti or Epanova surpass the results of the RI trial.

sts66

11/30/19 12:35 PM

#230926 RE: jomama9231 #230872

It's not unethical to run CVOTs for drugs in the same class, or even different classes for the same indication - if it was, there would never be any new drugs approved that had better outcomes, the first in a given class/indication to get approved would be the end of the line - obviously that makes no sense. Just look at how many statins were developed, and currently PCSK9's are hot too - everyone trying to build a better mousetrap for the same indication.

For all we know CaPre or MAT-9001 could be superior to V in preventing CVEs, although the chances of us ever finding out are < 0.1%, neither company will be able to raise the cash to run such a big and expensive CVOT - but if they did find the money the FDA would certainly be interested in seeing the results, as would the medical community.