Ann: Meeting Requested with FDA on Revascor Accelerated Approval, page-120

This guidance on FDA's AA is a good read.

https://www.regulations.gov/document/FDA-2024-D-2033-0002

The download

Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry

Amongst many points that signify what FDA will acknowledge about the drug, it informs that by the time of approval a number of milestones will need to have been;

Reached: e.g., safety and effectiveness and evidence that a surrogate endpoint will reasonably likely predict clinical benefit, or

Underway, e.g., the confirmatory study.

Also, it explains AA means, (general) patients (outside the confirmatory study) will have access to to the drug (understood paid access) once AA is granted.

The guidance also emphasises on the criticality of communication between FDA and the sponsor. My take from this there has been a lot of communication between FDA and MSB by now and as we speak. So, FINGERS CROSSED, news of the outcome is probably just around the corner.

I am holding tight ... and manged to top up in the past week or so,