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Alias Born | 07/17/2006 |
Monday, August 06, 2018 4:29:22 PM
At present none of us know the results..hopefully Vascepa reduces CVD event risk in a meaningful, statistical and robust manner..IMO that is highly likely..but yet to be confirmed..There are many, many other outcomes other than the PE...But we have been told the PE results will revealed before the end of Sept this year and JT suggested perhaps as early as the the beginning of Sept.
Most likely FDA will convene an AdCom sometime in the future..which may raise the anxiety levels of some longtimers..but this one is more pro forma...and should not be like the Oct "Red Wedding " Ad Com...
Neither the medical community or Amarin will be waiting for the FDA's permission to push forward...A successful CVOT R-I trial will speak for itself...Vascepa is already FDA approved...a successful R-I says it cuts CVD risk and that's all that counts...There will be no 1A issues.
We do not know what the individual RRR's will be..but if the the trial is robust..IMO death from MIs..CVD death will be one of the most most categories...
":>) JL
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