I agree with your comments. Do you anticipate soft tissue revenue in 2023? I think that if all goes well, there's a chance that there will be approximately 6 months of soft tissue revenue in 2023 which could help with the cash balance at the end of CY2023.
I'm anticipating the following for the soft tissue indication:
- Trial results around early June (given the 8 week primary outcome measures in the trial)
- PMA submission around September
- FDA decision 6-9 months later in March-June
- Commercial launch in the inpatient and outpatient centres soon after approval since they have the reimbursement code in place, approximately 1/2 of surgeons in high volume burn centres already trained also work in high volume trauma centres, access to Premier’s hospitals and providers, etc.
- BARDA funding the completion of the clinical trial, as well as Compassionate Use and ContinuedAccess programs, and possibly the development of the health economic model demonstrating the cost savings associated with the RECELLSystem
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