banter and General Discussion, page-9107

I think that's an unfair assessment of me based on one post. By the same token I could argue you have been brainwashed by the narrative put forward by Mesoblast.

If you look at the second CRL issued in August 2023 it is clear that the FDA has requested an additional trial to obtain more data suggesting this is the only way forward as there is no mention of additional potency assay work as an alternative.

Then in the type A meeting announcement a few months later, the narrative changes in that additional potency assays tests can be completed which would negate the need for a trial if successful. Which is why I suggested Mesoblast may have been able to negotiate this as a viable solution.

The narrative has not changed since and it feels like the need for a trial prior to approval is gone. My point is that Mesoblast was very confident when answering the first CRL that all CMC issues were resolved and I believed them.

I'm not suggesting that Mesoblast is ignoring fda recommendations for another trial but to completely rule out that the FDA will not play along or knit pick data even if potency assay data is seen as strong is ignorant. I'm more skeptical of the FDA more so than believing Meso is being insincere.

Don't confuse me with the resident downrampers here, I still like our chances. it's just a thought to keep a level head and personally for me not to believe everything is as straight forward as it appears like I did last time. I agree with your summary of where we are based on what we have been told, I'm questioning whether it'll be that straight forward when push comes to shove.