A partnership in CHF will be the confirmation the market needs...

A partnership in CHF will be the confirmation the market needs ...... and yes regardless of what the naysayers are claiming, all the data from all of the CHF trials conducted by Mesoblast in adults and children point to the increased possibility of an Accelerated Approval - even if this is in a limited / restricted cohort .... for those that want to read up on the AA process, here's the link


Today's announcement is a positive update in what has been an otherwise announcement vacuum so take it as a win (even if small at this stage) .... GLTAH


https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program

Accelerated Approval Program


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.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.