Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-66

another trial will be required

You keep saying this when nobody on here has said another trial isn't required ? For a supposed doctor it baffles me that you don't comprehend that an Accelerated Approval is in fact an approval even though it requires a Confirmatory Trial to take place post the approval advice.


You have argued for years on here that the FDA would never entertain an Accelerated Approval pathway for CHF while others on here (myself included) promoted the fact that the FDA would based on such great data from the LVAD and DREAM-HF trails and the subsequent RMAT Designation awarded for Rexlemestrocel-L .... and yet here we are awaiting a Pre BLA Filing meeting with the FDA for an AA for exactly that





I have enclosed the following links (AA and RMAT) in case you want to do some further research on the matter because you clearly have no idea how the USA FDA system works with some of what you have posted on the Mesoblast threads .... enjoy your day !


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.



https://www.fda.gov/vaccines-blood-...erative-medicine-advanced-therapy-designation

Regenerative Medicine Advanced Therapy Designation