Request Letter for PRE-IND Meeting

Attachment 1
Valsartan ER Tablets
CMC-PK and Phase 1 Clinical Study Summary

Corporate: EZRA Pharma DBA 4301 W. Markham Street #831 Little Rock, AR, 72205
Courier:
401 South Cedar Street Little Rock, AR, 72205

Table of Contents
1.0 Product Name ................................................................................................................1
2.0 Chemical Names and Structure .....................................................................................2
3.0 Proposed Indication........................................................................................................2
4.0 Type of Meeting Requested ...........................................................................................2
5.0 Statement Purpose of Meeting .......................................................................................3
6.0 List of Specific Outcomes Expected from the Meeting ...................................................3
7.0 Proposed Agenda Items .................................................................................................3
8.0 Draft List of Questions ....................................................................................................4
8.1 General/Regulatory .............................................................................................4
8.2 Non-clinical ..........................................................................................................4
8.3 Clinical .................................................................................................................4
8.4 Chemistry, Manufacturing and Controls (CMC) ...................................................5
9.0 Meeting Attendees .........................................................................................................5
9.1 EZRA Attendees ..................................................................................................5
9.2 Consultant Attendees ..........................................................................................5
9.3 Requested Agency Attendees .............................................................................5
10.0 Suggested Meeting Dates and Times ..........................................................................6
11.0 Approximate Date of Submission of Briefing Document ...............................................6

Corporate: EZRA Pharma DBA 4301 W. Markham Street #831 Little Rock, AR, 72205
Courier:
401 South Cedar Street Little Rock, AR, 72205

Corporate: EZRA Pharma DBA 4301 W. Markham Street #831 Little Rock, AR, 72205
Courier:
401 South Cedar Street Little Rock, AR, 72205

Corporate: EZRA Pharma DBA 4301 W. Markham Street #831 Little Rock, AR, 72205
Courier:
401 South Cedar Street Little Rock, AR, 72205