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Biotech / Medical : Apricus Biosciences -- Ignore unavailable to you. Want to Upgrade?

To: eico20 who wrote (1499)	9/11/2015 2:30:47 PM
From: Mirror Image	1 Recommendation Recommended By mokelumne river Read Replies (1) \| Respond to of 2026

that's very possible MI as experience tells us, the limiting factor could be the approval or the manufacturing and distribution, the stable studies are set based on real time. Right. 12 Months of real time stability studies = 24 months of shelf life. Have you ever thought about the possibility of them reaching the 12 month timeframe and the product samples not being stable? It's not a 100% slam dunk ( not in my opinion ). Would they reformulate the room temperature version to have it achieve the desired duration? Then reinitiate the stability studies. Since I am on the subject, I believe they also would have samples targeting a 36 month shelf life ( 18 month stability studies ). I am not an expert here but I would think that they have had samples taken at different intervals prior to the 12 months - just in case - they reach 12 months and the desired stability is not there ( just common sense ). A room temperature Vitaros with a 9 month shelf life is better than the current cold version. Maybe even a 6 month shelf life room temperature Vitaros. Those are the current shelf life durations for the approved Canadian Cold Version Vitaros versions. The first-generation Vitaros® product (“Cold Chain Vitaros®”) is stored in one chamber of our AccuDose® dispenser. This single-chamber formulation requires that the product be stored by customers in a refrigerator until a short time prior to use. Cold Chain Vitaros® was the product used in the Company’s clinical trials, and was approved in Canada and Europe. In November 2010, Health Canada approved Cold Chain Vitaros® for a current shelf-life of nine months for the 330 micrograms (“mcg”) product and six months for the 220 mcg product. These shelf-life durations are calculated at a temperature of 2°C-8°C. At room temperature conditions, Cold Chain Vitaros® has an approved shelf-life of up to seven days. Therefore, Cold Chain Vitaros® can be conveniently carried by the patient and brought up to room temperature prior to use. In June 2013, through the European DCP, Vitaros® was approved for a current shelf-life of eighteen months for the 300 mcg product and nine months for the 200 mcg product. These shelf-life durations are calculated at a temperature of 2°C-8°C. At room temperature conditions, Cold Chain Vitaros® has an approved shelf-life in Europe of up to three days through the European DCP. Being stored at room temperature versus cold storage is KEY. Of course the shelf life duration also plays a crucial roll and that is what they are trying to prove with the longer stability studies. The more shelf life - the more confident all parties ( Apricus, the different partners and the end users ) will be.