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Re: ziploc_1 post# 33233

Sunday, 08/31/2014 8:13:29 AM

Sunday, August 31, 2014 8:13:29 AM

Post# of 427818
Agree, it is history, we have to concentrate on the present and future.

The current situation is a non-sense, it is over a normality and very frustrating to all long (including myself). Most of the posters try to add something useful (facts or assumptions). Sometimes the assumption is not good, but supported by something.

Just an example:
BB expected the unsealed document on 08/28 based on a document submitted on 08/25 contains „… file a public brief within three days …”. So his assumption has a background. The reason, why he was wrong that the document was submitted by Amarin and it was a “Proposed Order” not a Judge’s order.

Regarding the “all FDA wanted, saving face and revising the SPA” in 2014, everybody has to make own judgment. It’s logical or not, realistic or not. I have my own based on facts, as:

SPA: it’s about the study (size, design, etc.) and nothing else – ANCHOR SPA: 19 May 2009
SPA sometimes modified before and during the study – ANCHOR modification: 10 March and 27 May 2010
ANCHOR start and end: 16 December 2009 – 21 February 2011
Study result (database unbliding): 29 March 2011
FDA accepted the study as it was according to SPA

My conclusion: revising the SPA in 2014 will not change the study (it was finished), the result and anything else, since it’s about the study only …

However, I have an open mind, so if anybody has any idea how could be the SPA revised after the study finished and result released to affect anything, let me know.
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