Subject: Fwd: Pre-Sub Draft
From: "Paul" <[email-masked]>
To: "Hunter" <[email-masked]>
Date: Wed, 12 Nov 2014 20:05:51 -0500

H:
FYI - for your eyes only - see you at Daily Grill tomorrow evening 7:30pm
PR

Sent from my iPhone

Begin forwarded message:

> From: Derrick Johns <[email-masked]>
> Date: November 12, 2014 at 7:47:36 PM EST
> To: paul rowan <[email-masked]>
> Subject: Fwd: Pre-Sub Draft
> 
> ---------- Forwarded message ----------
> From: "Deborah Grayeski" <[email-masked]>
> Date: Nov 12, 2014 2:02 PM
> Subject: Pre-Sub Draft
> To: "Joyce Ludwig" <[email-masked]>, "Derrick Johns" <[email-masked]>, "Chuck Jaggers" <[email-masked]>, "Joe" <[email-masked]>, "Sriram Sankar" <[email-masked]>, "Ranjani Madhavan" <[email-masked]>, "felix kraeft" <[email-masked]>
> Cc: "Marie Marlow" <[email-masked]>, "Vladimir Scerbin" <[email-masked]>
> 
> Hello all,
>  
> Attached is the pre-submission draft document.  I have a number of comments in the attached for discussion.  The preclinical section is still a bit scattered, but I thought it would be best to discuss first, so that I don’t waste time organizing the section incorrectly.  I think we should schedule a separate telecom to go through the document.  I’m available anytime tomorrow before or after the recurring call, and I’m available Friday morning as well.  Please let me know what would work best.
>  
> Thanks,
> Deborah
>  
>  
> Deborah Lavoie Grayeski
> M Squared Associates, Inc.
> Office: 703-562-9800 x250
> Mobile: 202-550-7395
>  
> [email-masked]
> www.msquaredassociates.com
>  
> This e-mail communication and attachment may contain confidential and privileged information for the use of the designated recipients. If you are not the intended recipient, you are hereby notified that you have received this communication in error and that any review, disclosure, dissemination, distribution or copying of its contents is prohibited. If you received this communication in error, please notify me immediately at [email-masked]. Thank you.
>  
>  
> -----Original Appointment-----
> From: Joyce Ludwig 
> Sent: Tuesday, September 02, 2014 10:28 AM
> To: Joyce Ludwig; Deborah Grayeski; 'Derrick Johns'; Chuck Jaggers; Joe; 'Sriram Sankar'; 'Ranjani Madhavan'; 'felix kraeft'
> Subject: Weekly (NEW SERIES) update meetings DiFusion CleanFUZE PEEK
> When: Thursday, November 13, 2014 11:30 AM-12:30 PM (UTC-05:00) Eastern Time (US & Canada).
> Where: telecon +1 646 653 6780 Participant code: 19142521#
>  
>  
> ~~~~~~~~~~~~~~~~~~~
> A ShoreTel conference call has been created for this meeting.
> Use either of the following to join the call:
>         16466536780
> Participant code: 19142521#
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> Or, click the link below:
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> Mobile Auto Dial:
>         iOS devices: 16466536780,19142521 and press #
>         Other devices: 16466536780x19142521#
>  
>  
> Team meeting to track progress –
> Quality Systems/ Validation of Processes / Technical File / Master File
> Regulatory Strategies US and EU
> Additional Topics
>  
> =2