"This is why people that actually understand stats don't buy it."
Well then the FDA must be some what lacking when it comes to stats. They ask for the current stock to be the same as used in 001. They also acknowledge the improved potentcy assay. Better tell the FDA they have it all wrong.
Then you have the ODAC members 9 - 1 said that the data was good.
Hundreds of millions of dollars have been spent on countless trials on MSCs. Those responsable would not know any thing about stats.
You can also add to the long list of those that have no understanding of stats. The idots that claim that MSCs show promise in all those study reviews. The clowns at the top, both EU and Japan, almost forgot Canada and NZ.
And yes I hear you, its all promise and no proof. Not sure that the hundreds saved by Remestemcel-l or Temcell would agree. But lets face it the above is about MSCs in general, Temcell and Remestemcel belong at the upper end when it comes to proof of efficacy, that is why they have been given approval.
Now we have Ryconcil , the best of Remestemcel. The Chair Elect Dr John Levine said the data from children was compelling. I agree but what do I know. We should only take note of the two on this board that have any understanding of stats.
Now you DocNots , care to tell us why the NHLBI see no reason to have a control that you think is the only way to go, in this trial . NCT 00224874 And when you go and look you will see that most only have grade 1 and 2 aGVHD. I wonder why grade 3 and 4 are so light on? Is it that they were given the best available , like Remstemcel?
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