Replies to post #1575 on Palatin Technologies Inc. (PTN)

[Rogerthat1]

From the 10K

We enrolled a combined total of approximately 1,250 randomized subjects in the two pivotal efficacy studies, which are double blind placebo-controlled, randomized parallel group studies. Each study had two arms, one a 1.75 mg bremelanotide dose and one a placebo. The double blind or efficacy portion of each study consisted of a 24-week treatment evaluation period, with primary and key secondary endpoints of satisfying sexual events, or SSEs, the Female Sexual Function Index, or FSFI, desire subdomain (a 28 day recall), and question 13 of the Female Sexual Distress Scale-Desire/Arousal/Orgasm, or FSDS-DAO, questionnaire.
The last patient visits for efficacy portion of the RECONNECT STUDY were completed in the third quarter of calendar 2016. Patients in the efficacy portion of the RECONNECT STUDY had the option, after completion of the randomized portion of the study, to continue in an open-label safety extension study, in which all patients receive the 1.75 mg bremelanotide dose. The open-label safety extension study has enrolled approximately 680 patients.

Efficacy portion = double blinded population that includes both control arms - drug and placebo.

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