@rdeguara I've been looking at my inbox each morning hoping to...

@rdeguara I've been looking at my inbox each morning hoping to find an email alert from Avita with a headline like:

AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Soft Tissue Repair in the U.S.

I originally thought JC was potentially setting himself/us up for disappointment with the June approval guidance for both soft tissue and vitiligo, given delays with FDA approvals seems to be the standard expectation. However, I've come around after hearing his explanations on why he's so confident of the approvals being granted:

• Clinical trial endpoints achieved
• Breakthrough device designation granted with priority review (FDA’s goal is to take action on an application within 6 months)
• No material deficiency notices (FDA's clock hasn't stopped for soft tissue or vitiligo)

I also gained some additional confidence in the FDA's ability to approve within 6 months by reviewing past BDD PMA approvals (some took longer but I'm assuming they may have had deficiency notices):

CDRH and CBER Breakthrough Device Marketing Authorizations Below is a list of CDRH and CBER Breakthrough Devices that have obtained marketing authorization.

Examples:

• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180051S001

• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210034
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210007

• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200046

Not long now