Thursday, September 10, 2015 2:17:16 PM
We had a same discussion one week ago, so I have to assume:
- you do not want or could not understand what I am saying or
- a post from HDGabor makes you see red and do not think before post
So,
- nobody said it belongs to the FDA, BUT the SPA is in place
- yes, "The company can do anything wants", but what a "surprise" they did not increase the TG enrollment criteria without SPA modification (-> FDA was involved)
- nobody said "Amarin does to change the trial design". Any analysis AFTER full enrollment isn't a change of the design and could not affect it since ALL patients were enrolled at the time of the analysis
- final: eff. 15%, p =< 0.046
- 60% interim: app. 25-27%, p =< 0.0076
I do not see any reason, why additional interim analysis @80% or @50% (AFTER FULL ENROLLMENT) could not produce meaningful data. ie:
- @80%: eff. 20%, p =< 0.025
- @50%: eff. 35%, p =< 0.005
All interim could provide a statistically meaningful and valid result.
To be more precise: the @50% will be a little bit higher and the more exact definition (independently from event number) is "interim after full enrollment)
Since time is money, both additional interim look (but again: if any) is could for Amarin (@"50" - 4 months earlier than @60 / in November, @80 - 11 months / halfway between @60 and @100)
Best,
G
#STRONGERTOGETHER
Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.
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