—for use with cystinosis through the special access program.
One of the products, an extended use product, Procysbi, applied for market authorization and received market authorization in June 2017. At that point we were still getting requests for both of the products through the special access program, knowing that it typically takes a manufacturer about three months to get their labelling in order and get it on the market. Knowing that in three months there would be an approved marketed therapy for this condition, it made sense that both requests for Cystagon and Procysbi were reduced to three months.
Our assumption was that most, if not all, patients would transition to the approved therapy. In fact, in the spring when this product was being reviewed and being announced as coming on the market, there was a lot of support from treating physicians who were involved in this disease group as well as some of the patients who were out advocating that it was great that Procysbi was coming to market. Our anticipation was that, in three months, there wouldn't be a need for as many requests, if any, through the special access program; hence, we reduced it to the time period we thought would be required for a product to be accessed.