Well - yes I agree that: "Mesoblast will end up treating...

Well - yes I agree that: "Mesoblast will end up treating diabetic and/or ischaemic patients with inflammation (CRP>2 or maybe other measures of inflammation in the future) and those patients will be treated regardless of whether they are in Class 2 or Class 3". Whether it's the reason for not requiring another trial ... maybe indirectly? As in, the only purpose of another trial would be to identify a clinically relevant target population.

Keep in mind that the NYHA classifications are self-reported and pretty floaty. They rely on a patient responding to a questionnaire (or similar) and accurately disclosing the level of disease severity. This isn't super clinically relevant - it has a bunch of error and bias built into it and also requires quizzing your hospitalized heart failure patients. It is also a moving target, the same patient will change over time - which isn't great when you're trying to assign a treatment protocol.

NYHA Classification - The Stages of Heart Failure:

1. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
2. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20—100 m).Comfortable only at rest.
4. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Diabetics and ischemic are far more clear cut, someone with diabetes or ischemia is matter-of-fact and inarguable. Add the biomarker of >2 mg/L and you have a clear, measurable, clinically relevant target population.

I assume the FDA voiced this concern, recommended this further analysis, and now that MSB has performed it and it has come back with flying colours - they will submit for FORMAL FDA review:

I need to brush up on my regulatory terminology and process, but I read this as a formal submission for approval with the FDA to determine the best potential pathway to approval, immediately prior to proceeding down the said pathway.

Pretty exciting.

Also - as I think @col69 pointed out. The Cephalon deal was US$130 upfront, US$1.7b milestoned, and a 20% stake worth US$220m at A$4.35 per share. This partnership came after phase 2a data. We have now gone through a 5-year long phase III trial and seem to have a good shout at being commercial next year. .... This has been massively derisked, and accordingly this old partnership has set the precedent for any future partnership as the value of this indication has significantly increased. I hope that the partnership deal that is soon to close as referenced by Silviu in the ****** call is for this indication, I REALLY want my tesla.

Gang Gang