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CJR_MS

04/01/16 10:14 AM

#76360 RE: AVII77 #76357

AVII77...

I'm pretty sure you should host your own conference call. Not even kidding. Not even a little.

Sign me up.

Hope that you reveal your background at some point.
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BioChica

04/01/16 10:17 AM

#76361 RE: AVII77 #76357

Excellent post AVII77 - Several months Amarin referenced in the PR released probably translates into 4-5 months and the DMC decision within the 6th month time frame.

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ggwpq

04/01/16 10:21 AM

#76364 RE: AVII77 #76357

AVII, thanks for the clear explanation of the interim review process. You said, " IMPROVE-IT trial and zetia didn't get the label expansion even though the results were Stat Sig", IMPROVE-IT's RRR is 6.2%, less than 10% it's looking for. Is it still stat sig? Do you know why R-I is shooting for 15% instead of 10%?
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marzan

04/01/16 10:37 AM

#76370 RE: AVII77 #76357

Dear AVII, what is SC?
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Whalatane

04/01/16 11:09 AM

#76375 RE: AVII77 #76357

AV11 Excellent post Thx .

You've either taught bio stat /clinical trial design class's, run clinical trails or worked on DSMB's...or all 3 .

Only one little quibble ...re 967th event ...its June 2 ...:>)
( note Gabors contest ).

Very much appreciate your contribution to the board .
Kiwi
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Bogussmogus

04/01/16 11:22 AM

#76377 RE: AVII77 #76357

AVII77,

So you believe that the 967th event may not (or may have ) have occurred. It is first necessary to scrub data to determine accuracy of events. ie someone could have gone to the emergency room with chest pain, but it may have been from indigestion. So, events must be verified. Correct?
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sts66

04/01/16 3:06 PM

#76413 RE: AVII77 #76357

But for those looking for a date of event 967, I would use something like June 1, maybe even July 1



Huh? There couldn't possible be enough time to adjudicate, analyze, and transfer data in order to have DMC review it 6 months from now if that were true - and RRR would be massively high if it took that long to reach #967, unless you meant June/July of last year, which I'm pretty sure you are not saying, as that would be a disaster for the trial (way too early).

I know you didn't see this until after you posted, but it confirms what we think - #967 is believed to have occurred and it's working it's way through the process:

IR response to @greenday regarding 967th event timing,

https://twitter.com/greenday_bio/status/715909023741186048/photo/1



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CaptBeer

04/01/16 3:35 PM

#76418 RE: AVII77 #76357

Quote
But for those looking for a date of event 967, I would use something like June 1,

Well what do you know! That's my guess in the Guess The Date Contest!

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Sam81

04/01/16 4:18 PM

#76427 RE: AVII77 #76357

Thank you AVII, now we know all the steps. Personally I'm glad as I learned something new :)
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zumantu

04/01/16 4:46 PM

#76432 RE: AVII77 #76357

AVII77,

if what you suggest is true (June event) it speaks to a probability of an interim stop - do you agree?

Have you thought about mortality by interim given the population profile ( Diabetics with CVD)?

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ggwpq

05/19/16 8:43 AM

#80861 RE: AVII77 #76357

AVII, your april post implies the 967th event might took place closer to June 1st than March 31st, or I read it wrong?