Source: http://www.earningsimpact.com/Trans...----JMP-Securities-2013-Healthcare-Conference
Quotes...
"And finally I would recognize that we've inevitably had to raise money and we've been successful in actually doing that. So, let's start out with the first one, which we believe is the most significant barrier to sales for Qsymia in the market place and I will tell you just a little bit of a story going back, I think most of the people in this room are very familiar with it, but I think it bear repeating. When we actually received approval almost a year ago now, it was with a REMS modification or -- which was very restrictive on sales, I think everybody recognizes that. This was done with the FDA and the advisory panel for a very specific reason.
Given the risk associated with other products previous risk associated with other products in this area, they felt that they did not want a public health experiment going on with Qsymia. They recognize the superior efficacy as a product and it had the kind of efficacy that FemPharm had etcetera. So, they are interested in the advisory community was interested in putting a governor on sales. No one realize how severe the governor that was actually put on sales was, but we certainly do now."
Quotes...
"And finally I would recognize that we've inevitably had to raise money and we've been successful in actually doing that. So, let's start out with the first one, which we believe is the most significant barrier to sales for Qsymia in the market place and I will tell you just a little bit of a story going back, I think most of the people in this room are very familiar with it, but I think it bear repeating. When we actually received approval almost a year ago now, it was with a REMS modification or -- which was very restrictive on sales, I think everybody recognizes that. This was done with the FDA and the advisory panel for a very specific reason.
Given the risk associated with other products previous risk associated with other products in this area, they felt that they did not want a public health experiment going on with Qsymia. They recognize the superior efficacy as a product and it had the kind of efficacy that FemPharm had etcetera. So, they are interested in the advisory community was interested in putting a governor on sales. No one realize how severe the governor that was actually put on sales was, but we certainly do now."