EA Review #1, NDA 20-358

Page 13

is included in Attachment VI that curricular vitae for (whited out) are on file at (whited out) headquarters and have been reviewed by Burroughs Wellcome Co. to determine that (whited out) personnel are qualified to conduct the studies.

Adequate.

13.

Certification:

Provided.  Adequate.

14.

References:

Included.  Adequate

15.

Appendices:

Appendices include data summary for all of the studies cited for the drug substance, a Material Data Safety Sheet, study reports, curricular vitae of authors, and two confidential appendices providing information on identification of chemical substances and release of substances into the environment.

Adequate.