Why did you feel the need to include a disclaimer at the end of the film?

That's a very valid question, and that's something that we're also going to look at in these focus groups. The honest truth is that the industry we're currently in is heavily regulated. Even when you come up with a novel idea, such as presenting the story of patients in a unbranded way, there are still requirements from the FDA that you have to adhere to. And we worked very closely with FDA consultants, people who had worked for the FDA or DDMAC at some point in time, and had them evaluate the film.

Does it land on people in a way that may be unfavorable? We don't know. Hopefully, the focus groups will give us some more guidance on that and give us information that we could actually take back to the FDA for a discussion about what is necessary and what is not. Until then, this is something that we feel accurately covers the important safety information associated with all biologics, including ours.

Any time you're breaking new ground and are trying to find new ways to communicate with the general public or physicians, you have to be aware of the environment that you're launching these innovative ideas into. We're currently at a point in time where there are a lot of discussions on the Hill and in the media about direct-to-consumer activities and marketing practices. We strongly feel that, even though we're breaking ground, we have to adhere to the policies and the regulations that have been put in place. By doing so, hopefully we will continue to put innovative programs out there and continue to build trust within the general public.

Do you see feature-length health-education movies as a DTC medium that might catch on?

I think so. Just given the response that we have had from the general public, from physicians, from patients, from patient-advocacy groups, we've found something that resonates with people. I would find it hard to believe that this is not reproduced in some way, shape, or form.