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Biotech / Medical : Regeneron Pharmaceuticals
REGN 784.45-0.4%Nov 26 3:59 PM EST
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To: scaram(o)uche who wrote (1770)6/10/2015 3:22:18 PM
From: Biotech Jim1 Recommendation

Recommended By
Thehammer

  Read Replies (1) of 3559
 
<"balls"

Spot on.

Further, if you listened to FDA AdComs over the years you see that the academic docs at least, if not others as well, often make comments about unrealistic efficacy readouts for long term treatment drugs (sometimes justified). They are also very concerned about pricing, and even though they are not supposed to comment on such - it is a scientific/clinical review - , they often bring this up when consulting in an NDA review. They are afraid that the PCSK9 class will be used instead of statin therapy possibly as well, but this is impossible considering efficacy and price points of the PCSK9 class vs the statin class. In this case however, they want a long term treatment drug proven safe beyond a doubt to get an efficacy/safety yes nod. In the case of alirocumab, they did not say but would in all likelihood want cardiac safety outcomes for all patient classes that take the drug, eg the statin intolerant.

No balls for all reviewers to approve the drug for all qualifiers and based on further data possibly restrict the label, and let the treating docs make the decision along with the patient for treatment options.
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