MSB has data demonstrating that Rem-L and Rex-L response...

MSB has data demonstrating that Rem-L and Rex-L response biomarkers (e.g. MAP scores for aGvHD; CRP for CHF) are positively associated with 'gold standard' outcome data (i.e. overall survival outcomes for aGvHD and decrease in MACE for CHF). What's more these treatments have an excellent safety profile and have been shown to work long-term (improve survival over 4 years for Rem-L in aGvHD; and a single injection reducing MACE and progression of CHF for Rex-L in CHF).

At the end of the day the FDA is charged with approving drugs/vaccines/biologics that have a positive benefit to risk profile. IMO we have the risk side of that equation 'in the bag'; and IMO have generated convincing 'gold standard' outcome data for patients that meet the biomarker cut-off data. We will shortly see if the FDA agrees with my (and some other holders) analysis of approval prospects.

IMO the fact that MSB has identified such biomarkers that better predict patient outcomes is a good thing. It gives the FDA a very convincing arguement to approve Rem-L and Rex-L for these patient groups that meet the biomarker cut-off data (and other measurable factors such as diabetics for CHF). IMO we are at the very least a great chance to have our products approved for patients meeting these pre-specified criteria. IMO we at least have an excellent chance for conditional or full-approval for these patients with the data we have on hand (with follow-up Phase IV study if necessary). Let's also not forget 'off label' usage for patients that fall outside these biomarker thresholds (if indeed the FDA limit our therapies to the patients found to respond the best).

Lastly, this is likely a positive story when we negotiate reimbursements with payers as the identified subgroups have been shown to have exceptional benefit, thus promoting confidence for the individual treatment effect above a certain biomarker threshold (to be given high priority).

Now relaxing and looking forward to BLA acceptance and CHF peer reviewed article. Happy days ahead (fingers crossed).