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IgnoranceIsBliss

11/12/19 5:27 PM

#225035 RE: wmartin100 #225030

Yes, good framing

The FDA is conceding the secondary group from the trial, and then asking for input on how far to go beyond that.

The docs do NOT have the tone of saying, "Just secondary". They have the tone of saying, "Maybe we should just stick to Cohort 2 -- the primary prevention group from the trial."

In other words, the best case scenario from the dumb GS guy's report.

Biobillionair

11/12/19 5:32 PM

#225039 RE: wmartin100 #225030

Great explanation. Risk Cohort 2 skips at risk 30-40 yo with two or more risk factors...it makes no clinical sense.

A 30 yr old with Htn, Trigs of 134, family history of CAD, who is borderline diabetic is a frigg'n heart attack just waiting to happen!...yet not eligible for V for 20 years... THIS IS NOT PREVENTION it's suicide/homicide by math.


Some M.D. please discuss above....


BB

Pittkid

11/12/19 5:38 PM

#225042 RE: wmartin100 #225030

Thanks for the post explaining the options for the indication!

sharinky

11/12/19 6:12 PM

#225058 RE: wmartin100 #225030

I did not read it that way. They are saying patients with established CVD, plus 1 and/or 2. They are three different populations. It is not an either or.