Thomas Chaly, Ph.D., FAIC: Fluorodopa F

14, and 16, April 5, June 7, July 19, August 13 and 21, September 16, and October 10, 2013.

Significant deficiencies have been identified in the referenced literature studies and in the studies you have conducted in support of this application.

The data submitted in your application are not sufficient for evaluating the diagnostic effectiveness and usefulness of Fluorodopa F 18 PET in the proposed patient population.

Fluorodopa F 18 PET scan as the standard of truth for measuring the test's performance characteristics.

Fluorodopa F 18 as 100% for sensitivity and 100% for specificity.

For these patients a Fluorodopa F 18 PET scan provides no additional clinically useful information.

However, Study #21 does not provide substantial evidence of efficacy for the following reasons:

You have not adequately responded to our requests for information dated December 28, 2012 and May 31 and July 2, 2013. The following issues remain outstanding:

4. Provide validation data in the drug product section of your application for the drug product HPLC chemical and chiral purity method establishing the limit of detection and quantitation, accuracy, precision, linearity and robustness.

This data was not included in your August 21, 2013 amendment, as stated in your cover letter.

8. Provide English translations of current approved foreign labeling not previously submitted.

Letter states that these assessments will include interviews with applicants following FDA action on applications reviewed in the Program.