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`kate dawson/cambridge/biogenidec;nsfil<ate.dawson@biogenidec.com;smtp
`Mon Jul 17 2006 08:10:11 EDT
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`ratna lingamaneni/cambridge/biogen@biogenidec;
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`gilmore o'neill/cambridge/biogen@biogenidec;minhua
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`yang/cambridge/biogen@biogenidec;tammy sarnelli/cambridge/biogen@biogenidec;
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`Subject:
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`Re: EOP2 document- Safety data from C1900
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`Summarizing for the group after several conversations/emails.
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`Gilmore has rewritten/editted Section 7 and will be sending it to me later today.
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`We agree that a summary of the data/rationale from the Response to Clinical Hold should be
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`included, and that a link to the full submission established so that FDA can (re)review in detail.
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`Safety data should be presented in tables as is possible, and we understand that the psoriasis
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`exposure safety table will not be available prior to publishing tomorrow, but we hope to have it
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`later this week.
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`C-1900 safety data and tables should either describe blinded and safety extension phases
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`separately OR blinded and then overall.
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`Rationale for testing/safety monitoring in the Ph 3 trials (ie cardiac, liver, no esophago-
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`gastroscopy) should be tied to the data.
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`Please correct if these assumptions are not correct.
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`Kate
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`Ratna Lingamaneni/Cambridge/Biogen
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`07/17/2006 08:42 AM
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`Message Size: 15.8 KB
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`Kate Dawson/Cambridge/Biogen@Biogenldec
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`Gilmore O'Neill/Cambridge/Biogen@Biogenldec, Minhua
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`Yang/Cambridge/Biogen@Biogenldec, Tammy Sarnelli/Cambridge/Biogen@Biogenldec
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`Re: EOP2 document- Safety data from C1900
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`Page 1 "f5
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`Biogen Exhibit 2344
`Coalition v. Biogen
`IPR2015-01993
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`Page 1 of 5
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`Biogen Exhibit 2344
`Coalition v. Biogen
`IPR2015-01993
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`Hi Kate,
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`I think that we have the AE tables available for total BGl2 experience - a draft Version was
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`included in the IND clinical hold response, that was later updated following the database lock. l
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`guess we could include them in the document if they are readily available.
`-Ratna
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`Kate Dawson/Cambridge/Biogen
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`07/17/2006 08:07 AM
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`Message Size: 13.2 KB
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`To
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`Ratna Lingamaneni/Cambridge/Biogen@Biogenldec
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`Gilmore O'Neill/Cambridge/Biogen@Biogenldec, Minhua
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`Yang/Cambridge/Biogen@Biogenldec, Tammy Samelli/Cambridge/Biogen@Biogenldec
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`Re: EOP2 document- Safety data from C1900
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`I will check with Gilmore regarding this section and authoring. When this information is
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`included, do we just need to:
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`write about the extension phase in text, or
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`re-run the 5% AE table with all data, or
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`have separate and combined tables?
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`Do these already exist in the C1900 CSR?
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`Kate
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`Page 2 of 5
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`Page 2 of 5
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`Ratna Lingamaneni/Cambridge/Biogen
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`07/17/2006 07:32 AM
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`Message Size: 10.7 KB
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`Minhua Yang/Cambridge/Biogen@Biogen1dec
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`Kate Dawson/Cambridge/Biogen@Biogenldec, Gilmore
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`O’Nei11/Cambridge/Biogen@Biogenldec, Tammy Sarnelli/Cambridge/Biogen@Biogen1dec
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`Re: EOP2 document- Safety data from C1900
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`Hi Minhua,
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`At the last review meeting (on July 7th) this issue was discussed and it was agreed to update the
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`safety section to include the information from both part 1 and 2 of the study in the package for
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`completeness. I believe that Gilmore is working on this for the next Version.
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`-Ratna
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`Minhua Yang/Cambridge/Biogen
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`07/14/2006 04:31 PM
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`Message Size: 1472.1 KB
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`Ratna Lingamaneni/Cambridge/Biogen@Biogenldec
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`Kate Dawson/Cambridge/Biogen@Biogenldec
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`Re: EOP2 document- 1 comment
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`Page 3 of 5
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`Page 3 of 5
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`Hi Ratna:
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`1 don't know if 1 have the most recent Version of the briefing document, but in the doc you sent
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`me below, on Pag 51-52, we need to make it clear we are only discussing data for the placebo-
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`controlled phase. For example, On page 52 2nd paragraph, when we say " 7/256 subjects
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`withdrew fromt eh study, it is only referring to the part 1 placebo-controlled phase.
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`-minhua
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`Ratna Lingamaneni/Cambridge/Biogen
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`07/06/2006 03:44 PM
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`Message Size: 1469.5 KB
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`Minhua Yang/Cambridge/Biogen@Biogen1dec
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`Subject
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`Re: EOP2 document
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`Hi Minhua,
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`Sure, enclosed is the current Version that was distributed to the cross-functional team. Tomorrow
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`we are having a review meeting (2 - 3PM, room 741) to go over the comments, let me know if
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`you could attend.
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`[attachment "EOP2 Meeting Package Second Publishing June 28 2006.pdf“ deleted by Ratna
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`Lingamaneni/Cambridge/Biogen]
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`-Ratna
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`Page 4 of 5
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`Page 4 of 5
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`Minhua Yang/Cambridge/Biogen
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`06-Jul-2006 03:39 PM
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`Message Size: 1.6 KB
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`Ratna Lingamaneni/Cambridge/Biogen@Biogenldec
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`Subj ect
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`EOP2 document
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`Hi Ratna:
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`Will you please include me in the EOP2 document emails? Thanks.
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`-minhua
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`Page 5 of 5
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`Page 5 of 5
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