still a bit early to predict the announcement.I'm predicting...

still a bit early to predict the announcement.

I'm predicting CRL. Insufficient data for substantial evidence. Ergo FDA don't have at least one adequate and well controlled trial yet. The GVHD001 long term survival data comes from too few patients (less than 25 had blood taken) and of that 25 some received multiple lots (what if it was the second lot not the first that was potent(?) and only 3 donors were used.

There is definately confounding in the data - the EAP data and the use of multiple lots - and confounding doesn't have to be a fatal flaw - if alternate explanations can be ruled out - so the confounding is removed - that is what I think MSB was effectively trying to do with the EAP 275 data - bring in more data points for correlation.

But if MSB really had a handle on the data - rather than were just hail marying (hoping) I think they'd have provided better science and stats in their public announcements.

So I'm predicting CRL. But without the detailed analysis to back such a prediction (accompanying here - I think I've put my arguments through this message board though) it really doesn't matter.

I don't think this is a matter of luck though at all. Its a matter of logic and reason and knowledge and (possibly error in logic or knowledge or reason on my part if I get it wrong).