OK, so everyone's a little down on this stock. It has been a bumpy ride, but let me give you a very good reason to hold on and be here for the eventual big time stock price rise! Actually, read and you'll know that you should be buying more.
Santarus and Pharming submitted a BLA for Rhucin in December. The acceptance of the BLA will be this month, sometime within the next 10 trading days. Acceptance means that the FDA will start their formal review for commercial approval. It normally takes about 10 months. It could take longer if they stop the clock to get questions answered. I don't believe that they have fast track on this one or it could have been 6 months.
In Europe, Pharming won a recommendation from the EMA last June. So, that's a good sign to me that we should be expecting approval by the FDA.
Santarus bought the U.S. commercial rights to the product last September for $20M upfront plus milestones and royalties. Pharming was strapped for cash prior to this deal and I believe that resulted in a very good deal for Santarus.
The CEO of Pharming said that the projected annual sales of the product should be about $200M annually.
This is a big deal and it continuously flies under the radar somehow. After the BLA acceptance press release, there is a much better chance that it won't and we could be back in the $4 plus range again.