Vaccines, Blood & Biologics
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Preclinical Comments - Gintuit
- In the Talking Points that were sent to you on December 13, 2010 following the telecon held on the same date, we requested complete study reports for all preclinical studies cited in our communication. We also included our definition for such a report in comment #1. This comment was:
Complete study reports should include, but are not limited to: 1.) a detailed description of the study design (i.e., description of animal species/animal models, control and test articles used, does levels, detailed procedures for test article administration and collection of all study protocol parameters, etc.); 2.) results for all parameters evaluated for each animal on study; and 3.) your analysis and interpretation of the study data.
Please note that, per this comment, the results for all parameters evaluated for each animal on the study should be included in the report. In your January 5, 2011 email communication, in response to this comment you stated that ‘Nonclincial studies will be provided in this standard format in Module 2.6.”
We note that there is no Module 2.6 containing preclinical data; Section 2.6 of the BLA submission contains summaries of the preclinical studies conducted. We thus have the following comments regarding the study reports you provided in Module 4 of the BLA:
- Please confirm that each study report in this Module contains all the available data that you have.
- Please provide a Table that lists each study submitted in Module 4. For each study, cite the date the study was submitted to the Apligraf PMA (P950032) and identify the submission type and number. If the study was not submitted to the PMA, please provide the regulatory file to which it was submitted and the submission date.