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Product-specific reports Primary Current batch report 98.13% HPLC purity Batch PP2601 Tested size 1mg Laboratory Research Use Only

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As discussed in the following responses, we continue to believe that the evidence submitted for the VersaVue TM Single-Use Flexible Cystoscope application fails to demonstrate a substantial clinical improvement as required

The HPG axis is responsible for the production of testosterone, the main sex hormone in males, other sex steroid hormones (dehydroepiandrosteroneDHEA, androstenedione, dihydrotestosterone, estrogen, and progesterone), peptide hormones (activin, inhibin, and follistatin, which are included in feedback mechanisms and spermatogenesis), production of spermatozoa (sperm cells), and sexual arousal (11, 15)