Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-68

You have claimed ad nauseam for 2+ years ("harping" - your words, not mine) that the FDA would not likely be interested in an AA for CHF and that a further 5 year phase 3 trial would need to occur and that we were years away from anything tangible with this indication .... all of us that argued that an AA is possible in a restricted cohort based on the stellar Rexlemestrocel-L results and are well aware that a confirmatory trial is required


It's funny to see you try and walk that back now after today's announcement ..... here's the announcement heading again just so you understand what it is about:




Does it guarantee Mesoblast will get an AA for Rexlemestrocel-L .... no but they are much closer to it than you will ever admit ..... IMHO watch a partnership unfold in 'short order' now that this FDA support for Rexlemestrocel-L has been announced .... the size / global pharma group will be an indication of just what they think of this advancement .... here's a reminder of the size of the last CHF partnership without the AA prospect and prior to the last phase 3 DREAM-HF trial data - just sayin'



https://www.fiercebiotech.com/biotech/cephalon-strikes-record-2b-stem-cell-pact-mesoblast

Cephalon strikes record $2B stem cell pact with Mesoblast


Regenerative medicine just got a big player to enter the game. Cephalon has locked itself in a tight embrace with Australia's Mesoblast, agreeing to pay $130 million upfront, $220 million for a 20 percent stake in the company and offering up to $1.7 billion in milestones in a high-stakes gamble on the biotech's stem cell programs.




Post #:61855786

It is not likely they'll get AA. I'm harping on about this purely because it keeps getting brought up over and over.


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But based on their reactions I would be very surprised at an accelerated approval prior to further studies... and that's been my point the whole time.