Request the Type C meeting and we’ll have a discussion about how we can put together an NDA package that would be suitable for resubmission. As mentioned, we have not yet submitted request. We will be submitting that request in August. They typically respond within a couple of weeks to let us know if the meeting is granted or not. And typically the timeline for a Type C meeting following meeting request to meeting date is roughly 75 days.
Unidentified Analyst: Got it. Thanks for the clarity.
Operator: Thank you. And one moment for our next question. And our next question comes from Colin Bristow from UBS. Your line is now open.
Yihan Li: Hi. This is Yihan on for Colin. Congrats on the quarter, and thanks for taking our question. So I guess our question is on the PTC518 HD program. So in terms of the US partial clinical hold, just wondering if you have already submitted the Part A data as well as the additional safety data to FDA yet and if there’s any feedback for the requirements from the FDA to potentially lift the hold? And also the second part on the same program, so for the dose escalation. So based on our data it seems like the 10-milligram will be very likely to reach your targeted HTT reduction goal of like 30% to 50% brain. And you previously noted you need some more data at low doses to further determine for the dosing escalation. So just wondering, could you please let us know what kind of data set you might need to see to make this decision?
And will this potential dosing escalation be included in your conversation with the FDA for the clinical holding team? And when will we expect to see the data, the next update? Thank you so much.
Matthew Klein: Thank you very much for the questions Yihan. I’ll start with the first question regarding FDA and the partial clinical hold in the US. Obviously, we were very pleased to see that the data that we presented in June on the first cohort of patients coming through the first part of PIVOT-HD demonstrated the drug was safe and very well tolerated. No serious adverse events, no evidence of peripheral neuropathy, no NfL spikes that have been observed in other therapies. So overall as strong as the safety record as we could have hoped for. Obviously we are continuing to monitor safety. We also mentioned that we have an independent DSMB that continues to meet and continues to support continuation of the study as it is. And also indicated based on looking at the 5-milligram and 10-milligram data as part of that into the cuts that they would support if we would decide to do so escalating to the 20-milligram dose.
We have submitted to the agency the safety data and our argumentation and support of reopening the study in the US. That process is still ongoing and obviously we’ll provide an update at the appropriate time. Regarding your second question on the dosing. You’re correct. We were — as we shared, we believe the 10-milligram dose both based on what we observed in terms of blood reduction in huntingtin protein of approximately 30%, as well as again seeing higher exposures in the CNS to the blood with a ratio of CSF to plasma of 1.5:1 gives us any reason to believe that we’re within that targeted range of 30% to 50% lower rate within brain cells. And so what we said is since we believe we are in the range is continue to collect data on the 5-milligram and 10-milligram dose cohort.
