I remember that graphic but can't find it again. The timeline from here is pretty simple though now that we're essentially done with the EFS.
- Next is the pivotal trial, which should enroll 900-1100 patients.
-First the pivotal trial design needs to be approved by the FDA, which should be relatively quick as the pivotal trial will basically be a repeat of the EFS but with many more patients and those patients will be followed for a longer time.
-Once the FDA approves, the trial has to be approved individually by each participating hospital and once a hospital approves it internally they can begin recruiting patients and implanting devices. We'll need at least 30 hospitals (the EFS had 5) and more are better to enroll so many patients as quickly as possible (Edwards is using 57 for their ongoing pivotal)
-Patients will likely be followed for a year after implantation (the EFS was 30 days). So that means the trial will be complete one year after the final patient is implanted.
- Then the data will be put into the correct form and submitted to the FDA for Premarket Approval and the FDA has 180 days to grant us Premarket Approval after which we can begin selling DurAVRs.
As for my guesses on the timeline:
-Trial approval should happen in the next few months.
-Individual hospitals will likely start their approvals late Q1 or in Q2.
-First implantations will probably start sometime next June-August.
-Finding and enrolling 900-1000 patients will take the most time, probably a year and a half to two years. So if the first patient is implanted June 2024, the last would likely be implanted anytime from December 2025 to June 2026. Then we wait for a year after the last patient is implanted.
-Once the trial is complete, it will take a few months to complete the paperwork for the FDA submission and the FDA then has 180 days to make their decision.
This is just for the pivotal. There could be a parallel smaller valve-in-valve trial run but that's still speculation.
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