Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Scott Henry - Roth Capital.
Scott Henry - Roth Capital
You certainly covered a lot in the prepared remarks, but just a couple of questions on the R&D side. First on Rifamycin, when do you expect to file the NDA for that product given the consecutive phase III study?
Gerald Proehl
Scott this is Gerry, we haven’t given that guidance at this point in time. I think we are probably slightly behind where the Budesonide filing will take place by anywhere between maybe 6 to 12 months is what I would say. Obviously we would like to get the first trial up and running to see how enrolment actually goes, but I think that’s probably a reasonable timeframe to expect us to file the NDA for the Rifamycin.
Scott Henry - Roth Capital
Does it tend to take one travel season per trial, I mean is that the gaining factor here or it would take two years to do each trial or one year per trial.
William Danby
Yes, one year per trial. We think that there is a fairly defined time period to recruit patients in different territories and location. I think David might want to comment on this. We’ve made a decision that because of the types of the traveler’s diarrhea, the bugs that are affecting patients in different parts of the world, what we would like to focus on is in Latin and South America for both studies if at all possible to get most of our patients. So, we’ll do that over a two year period.
Scott Henry - Roth Capital
Then staying on Rifamycin, I guess this is kind of thinking out loud, but some big news on rifaximin to treat IBS, and these are similar but they deliver in different places in the gut. Would you consider going back to Cosmo and perhaps looking for a line extension that may release in an area that could be more conducive to treating IBS given what we learned recently, how do you think about that potential expanded indication?
Gerald Proehl
We certainly had some early discussions with Cosmo about their technology and what they could potentially do. I think I would say it’s still early stages of discussions. Certainly, we’re looking at a number of potential indications to pursue as we’ve mentioned including diverticulitis cecum facile and some other things and including potentially IBS. So, it’s something that we’re focused on at least initially discussing with Cosmo and what’s the best pathway for us, we haven’t made any final decisions on that though.
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