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Biotech / Medical : Apricus Biosciences

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To: eico20 who wrote (1780)	3/28/2016 1:45:01 PM
From: mokelumne river	Read Replies (1) of 2026

This is what the 10K had to say about the room temp device (note the nomenclature change to "Room Temperature Vitaros"): "It is expected that the product ingredients in our second-generation Vitaros® product candidate (“Room Temperature Vitaros®”), will be stored in two separate chambers. This will allow alprostadil to be segregated from ingredients that cause it to become unstable at room temperature. The contents of each of the two chambers are then mixed in the dispenser immediately prior to use. This mixture is expected to result in the same pharmaceutical formulation as the approved Cold Chain Vitaros®. This proprietary stabilized dosage form is expected to allow the product to be stored at room temperature conditions with a current target shelf-life duration for Room Temperature Vitaros® of twenty-four months. We plan to perform the necessary equivalence and stability studies to market Room Temperature Vitaros® in Canada, Europe and other future-approved territories, and to seek to increase the shelf-life over time." (emphasis added) Note in the last sentence that the 10K did not discuss the timing of the studies (which should have been completed by now).

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