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Brensocatib timetable to market

MAC & Bronchiectasis | Last Active: 4 days ago | Replies (24)

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@schoolgirl

I too have been following the upcoming approval of brensocatib very closely. It provided a glimmer of hope for those of us with bronchiectasis. It seems that the expedited approval may have been axed, since the drug approvals office has been put on the chopping block by the current administration. The article below is dated February 24. Does anyone have any further information on this?
https://www.prnewswire.com/news-releases/insmed-announces-that-fda-does-not-currently-plan-to-hold-advisory-committee-meeting-to-discuss-new-drug-application-for-brensocatib-in-patients-with-bronchiectasis-302382854.html

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Replies to "I too have been following the upcoming approval of brensocatib very closely. It provided a glimmer..."

The way I read that is that that was a good sign, possibly meaning FDA liked the data they saw and did not need a meeting. Better data, fewer meetings, more efficiency?!