Saturday, October 19, 2013 10:26:40 AM
Does anyone recall if they were meeting to identify parameters for an SPA or just what the next steps would be...another PII or PIII. Whatever the outcome, they either walk away with a requirement to do another PII or a green light for PIII. I am confused why they would set-up a meeting for a Canadian PIII when they could use an FDA approval. Doesn't seem to make sense to pursue both? If they can achieve efficacy I think this would be the first drug approved for FSAD since it does not rely on a hormone. With the FDA, hormone use in post menopausal women equals cancer and I don't recall they have approved 1 drug because of the hormone issue.
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