So are you saying there is no need for an RCT? or that the FDA...

So are you saying there is no need for an RCT? or that the FDA simply recommended/suggested MSB perform one but that they could just generate more data to bypass this requirement? Would it be fair for me to say that your argument implies that there is no need for an RCT? If so then if the extra data stacks up then it is highly likely that the treatment will be approved.

My argument is the FDA requires an RCT as implied by their rebuttals during the ODAC meeting and the written responses to the BLA, as well as the legal requirement for at least one RCT. I have also extended my argument to suggest that MSB are trying to bypass this requirement and operate down a path that does not require an RCT. This has always been MSB's approach.

My view is that these viewpoints are still relevant today and hence I think it is 50:50 since it depends on whether the extra data can help overcome the legal requirement for an RCT. I still think the need for an RCT is still in play.

Your right, the CRL announcement does say "the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children". This is despite a Type A meeting where MSB pleaded it's case. So why did the FDA not just request additional data in place of an RCT? The recommendation for an RCT appears to rank highest on their list, so I would say it is important. No one knows exactly what wording was used in the actual CRL.

I'm not saying MSB need to perform an RCT, i'm saying that the FDA's stance is a RCT is needed whereas MSB are attempting to bypass this requirement. Obviously it comes down to whether 1) MSB have done enough and 2) if the FDA are willing to waive this requirement.

My views only, not advice.