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Posted On: 02/03/2020 2:31:58 PM
Post# of 149458
Re: ClosetInvestor #16703
I agree and my expectations are similar for Thursday.
I looked a little into Type C meeting over the weekend. Based on the timing of BTD filing and the type C request (response within 21 days and if approved meeting scheduled within 75 days), I somewhat expect the meeting to be granted and scheduled within the 60 days BTD response time. The more data and support the better. NP publicly stating that he hopes the outcome of the Type C meeting is approval with P4 confirmatory trial, which seems possible with enough strong data.
https://www.fda.gov/media/109951/download
I looked a little into Type C meeting over the weekend. Based on the timing of BTD filing and the type C request (response within 21 days and if approved meeting scheduled within 75 days), I somewhat expect the meeting to be granted and scheduled within the 60 days BTD response time. The more data and support the better. NP publicly stating that he hopes the outcome of the Type C meeting is approval with P4 confirmatory trial, which seems possible with enough strong data.
https://www.fda.gov/media/109951/download
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