Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-472

If your product meets the criteria for accelerated approval then it is eligible for accelerate approval pathway. From the FDA:

“The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.”

It appears that MSB is suggesting IL-6 is an appropriate surrogate endpoint. I have no idea if the FDA will accept this as it appears quite a novel surrogate endpoint, but MSB is still going to have to run another trial to show that rexlemestrocel-L lowers IL-6 levels. While the first trial may have seen this, because the trial failed its primary endpoint MSB can’t do any valid statistical analysis on the secondary or exploratory endpoints. While data mining is a valid way to generate new hypothesise that can be testing in a new trial, you can’t data mine your way to accelerated approval from a trial that failed.

The best way to look at all this announcement is positive news, but it is not likely to lead to approval, accelerated or otherwise, anytime soon.