Question-and-Answer Session
Operator
[Operator instructions]. And your first question is from Leland Gershell from Cowen and Company.
Leland Gershell
Hi, good morning. Thanks for taking my questions. With those seven patients treated with a dose in the re-exposure trial, any safety observations you can share with us from those dosing today?
Dr. Zeb Horowitz
Leland this is Zeb. The only thing that we can say at this point is that there is nothing really to report here. We will give a full analysis when it is finally complete. So, we have all the patients available to us enrolled, and they have all received at least one dose, some of them multiple doses. And it is just nothing, as we expected, there is just nothing to say about it at this point.
Leland Gershell
With the plan to submit some of that safety data to the FDA during your BLA review, could you remind us as to what the requirements of that data is from the agency and the interplay with the ultimate label for Puricase?
Dr. Zeb Horowitz
As I believe we said before in a number of settings, that this re-exposure study was really set up by the Company in response to demand by patients previously treated in the early trials and by their investigators, where these patients might have volunteered for a single dose Phase I study or the limited three-month Phase II. And since we reported the favorable data from the longer Phase III study, and they know we have the open label extension, they felt as early volunteers they were being denied access to a drug when they had no other effective treatment. Really that is the reason we set it up. Obviously, of course, it does hope to begin to address the question about is there any risk of safety risk to re-exposing patients to a long multi-year drug-free interval. This never came up at the FDA. It was not discussed when we were planning the studies. It did not come up as a topic at the pre-BLA meeting. And I anticipate it is not going to come up as a topic during the review. But the reason we are submitting it in the post submission safety update is there is a requirement for any clinical program if there are ongoing studies of any kind or ongoing safety information coming, even from a marketed product, the sponsor is obligated to report that according to an FDA-specified schedule. And the rules are very clear and they are not drug specific. But it is nothing to do with a specific request from FDA. That is the whole story.
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