`
`15: oz
`
`FDR-DDDP -> 913172751552
`
`1- Fax
`
`DIVISION OF ONCOLOGY DRUG PRODUCTS
`
`Center for Drug Evaluation and Rea earch, HFD-I50
`Parldawn Building
`5600 Fishers Lane, Rockville, MD 20857
`
`To:
`
`John Worzallal LILLY
`
`From: Alvis Dunson. Project Manager
`
`Fax:
`
`317 276-1652
`
`Phonr. 317 276-5052
`
`Pesos:
`
`1
`
`Fax:
`
`3014594-0498
`
`Plume: 301594-5767
`
`Date:
`
`January 6.2000
`
`R9:
`
`IND 40.061/serial nos. 200 and 201
`
`‘
`
`[3 Urgent
`
`El For Iiovlow
`
`D Please comment D Please Reply
`
`D Flame Ilocycio
`
`*
`THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY T0 WHOM IT IS ADDRESSED AND MAY
`CON TAIN l‘N'FORMATl.'0N THAT IS PRIVILEGED, CONFIDENTIAL AND PROTECTED FROM DISCLOSURE UNDER
`APPLICABLE LAW. lfyou are not the addressee, or a person authorized to deliver the domlment to the addressee. you are hereby
`notified that any review, disclosure, dissemination or other action based on the content ofthe communication is not authon'ze¢1 If
`you have received this document in en'or. please immediately notify usby telephone and return it to us at the above address by mail.
`Thank you.
`
`0 Comments:
`
`Please refer to your submissions (2) dated December 22, 1999, for LY23l514 (MTA).
`
`We have reviewed these submissions and have the following comment.
`
`The medical officer does not support adding vitamins to the ongoing mesothelioma registration trial.
`The medical officer has reviewed the letter (serial #201) and the Protocol Amendment l-l3E-MC-
`JMCI-l(c) (serial #200) and does not support the proposed plan to add vitamins to this pivotal trial.
`
`If you have any questions please call me at (301) 594-5767.
`
`Alvis Durison
`
`TEIIL
`EXHIBIT
`
`2100
`
`-79” W; 7W1“ 1315"
`
`361 82? 4598
`
`Pf-'lGE.1
`
`CONFIDENTIAL
`
`ELAPOO01345O
`
`Sandoz V. L111
`
`Lilly Ex. 2106
`IPR2016-00318
`
`2100
`
`Lilly Ex. 2106
`Sandoz v. Lilly IPR2016-00318
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