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Re: Pyrrhonian post# 90671

Wednesday, 08/31/2016 10:25:01 AM

Wednesday, August 31, 2016 10:25:01 AM

Post# of 423548
P-

original / pre-SPA / pre FDA discussion design (based on estimation):
- allow 5.9% p rate
- 6,990 patients

Final / SPA (Aug 2011) design:
- allow 5.2% p rate
- 7,990 patients

The estimation wasn't changed, just the design. The # patients was increased pre-SPA / months before the first enrollment (Nov 2011)

We are aware of two changes only:
- min TG increase: 150 -> 200 (May 2013)
- finalized statistical analysis, additional endpoint added (recently)

No amendment to add another 1,000+ patients occurred after the SPA / during the study.

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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