Question-and-Answer Session
Operator
Thank you. (Operator Instructions). Your first question comes from the line of Kim Lee with Wedbush Securities. Please proceed.
Kim Lee - Wedbush Securities
Couple of questions for you. First, just on the REMS program, can you clarify what is meant by a closed distribution system? What does that detail? And also what other elements aren’t do you think are not necessary in your REMS program? And finally, can you update us on how labeling discussions are going? Thanks.
Gustav Christensen
Thank you. Kim, I think Bill Pullman will answer this question.
Bill Pullman
The closed distribution system just to take that one first was designed to ensure that a patient who had a potential anaphylactic reaction would not receive any further doses of Kalbitor, unless they have been successfully recharged. In other words, it was confirmed that, that reaction was not mistaken for an HAE attack, but it was anaphylaxis. And the distribution system was linked critically to the mandatory healthcare professional and patient enrollment registry to ensure that contraindication for anaphylaxis was not violated, while still enabling access to the product for those who indicated for the product.
And as we said, the FDAs determined that those elements to assure safe use, no longer requested, because they wouldn’t facilitate protection access, while preventing anaphylaxis. And to our understanding all of the REMS moving forward is that will consist purely of the medication guide and a communication plan. So, we have lot of elements to assure safe use that we’ve previously I think highlighted are not required. I hope that answers your question.
Kim Lee - Wedbush Securities
Do you think that there won’t be any restrictions on the label then and about anaphylaxis than [high percent] of negative reaction?
Bill Pullman
Beyond that clarification, we simply can’t comment on what the FDA might require in the label. So, we can’t speculate until we’ve finished those discussions with the FDA. Thanks.
Kim Lee - Wedbush Securities
How have label discussions just going?
Bill Pullman
We continue in active conversations with the FDA on the dosier.
Operator
Your next question comes from the line of Mark Monane with Needham & Company. Please proceed.
Mark Monane - Needham & Company
Good morning and thank you for the review. Congratulations on your progress to-date internally and externally. Question for the team overall. There are a number of products now available for the HAE space to work out, till recently there was nothing available in the U.S. Maybe some comments from you on your market research what it’s shown.
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