Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Mark Monane with Needham & Company.
Mark Monane, M.D. - Needham & Company
It is 5:00 here and it is already quite dark and that is something new for us on the East Coast. Speaking of being in the dark I think a lot of patients and physicians who had experienced PTCL which is refractory therapy really had not treatment options and now there is obviously something new. So, my question has to do with what efforts are you planning in order to increase the physician awareness? Jim was nice enough to go over some market research, but I’m guessing, talking about specific programs. This, unlike Humera, which I know you have a lot of experience with, where there is already a marketed product and this may be another new product which has some advantages, this is something totally new. So, maybe you could talk about what efforts you all have to allow for earlier than expected sales or frontline sales to get patients on other incentive programs? Are there various strategies for wholesalers who could get the drug into the marketplace so physicians could start using it?
Paul Berns
In terms of the distribution channel, I believe that was one of the last elements of your question, we have established an exclusive distribution channel which quite frankly is very cost efficient for us, saves us significant expense and at the same time was developed in such a way where it is transparent to the healthcare providers and end users in terms of their standard of typical ordering process. So, we are very pleased in the distribution channel, which quite frankly was up and running approximately ten days post our PDUFA approval.
In terms of what we’re currently doing now, as I mentioned earlier as an accelerated approved drug we do work within the guidelines of DDMAC. It may take up to 120 days for them to review the content of the tactics that we have built out as part of our execution for our launch plan. It does not necessarily mean that we would not receive elements of those materials back prior to the 120 days.
I think when you look at how we currently address the situation we obviously planned for both, an accelerated approval and a full approval, so we have launch plans in place for both. We are currently, from an execution perspective, we have identified key healthcare providers, and institutions that we really believe treat the bulk of the PTCL population. As you would expect the 25 trained specialists that we currently have in play are in contact and connecting with those healthcare providers to communicate the clinical benefits of FOLOTYN for relapsed or refractory PTCL and we are executing on our strategic brand platform.
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