Replies to post #23203 on Amarin Corp Plc (AMRN)

[louieblouie]

I cant open all the documents but the FDA can certainly respond that because of the complicated science there will be a delay in the decision.

I'm wondering if biobillionairs finding today about the definition of NCE losing the 'ester' might have something to do with this.

[BioChica]

Not to mention the Lawyer was an FDA Employee, the filer. I believe BioWill contacted the Omnibudsman, our another poster, they said no conflict here! Oh really...

[sts66]

Not sure what we see is factual - on that page I find:

Comment
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Please see the attached supplement to the citizen petition and appendix.
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Crowell Moring Comment
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Authors: cder

I downloaded the original CP, the FDA/CDER interim response letter, and the CP comment claiming to be written by John Fuson - below are the PDF special properties:

Original CP filed by Crowell and Mooring:

pdf:Producer: Adobe PSL 1.1e for Canon
pdf:CreationDate: 2013-08-20T14:16:24-05:00
pdf:Creator: Canon iR-ADV 6055

FDA CDER Interim Response to Crowell and Moring LLP Letter

pdf:Producer: OmniPageCSDK16
pdf:CreationDate: 2013-08-16T07:54:39-05:00
pdf:Creator: OmniPage CSDK 16

Comment to CP supposedly authored by John Fuson/Crowell Mooring, but regulations.gov shows CDER as author on the website:

pdf:Producer: OmniPageCSDK16
pdf:CreationDate: 2013-02-11T10:08:21-05:00
pdf:Creator: OmniPage CSDK 16

As you can see, the original CP filed by Crowell and Mooring was created by the Adobe Canon app, while both CDER's response and the purported to be CP comment by Fuson, were both created using the OmniPage app - this is almost a smoking gun in my view, unless for some reason CDER took the original CP comment from Fuson and recreated it.

Federal government agencies require common platforms and software, and although employees can choose between Macs or Windows machines, the software is always consistent - I know, because I used to work for one - they buy "seats", or licenses, to use specific apps. Everyone uses identical software so everything is compatible and they don't have to deal with multiple vendors and licenses. The fact that different software was used by Crowell/Mooring and CDER is not a coincidence, and furthermore, I have to believe that CDER indeed authored that comment, not John Fuson or C&M - but WHY? This is too bizarre to believe!