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Friday, 03/19/2010 9:14:40 AM

Friday, March 19, 2010 9:14:40 AM

Post# of 5932
APPA Teleconference Notes.

First, be aware that these are just my rough notes, no attempt to clarify them or make them more readable has been made.

- FDA response recieved
- approval denied in current form
- concerns of cross-contamination during transfer
- further dialog needed but believe admendments address this
- sterlization work has been done but needs to included in application
- clinical efficacy test not needed
- 2 test needed
- Will have meeting with FDA
- FDA has not reviewed all admendments
- Believe some or most of FDA concerns have been addressed in admendments
- Plan resubmission as soon as possible

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