banter and General Discussion, page-4691

OK let's just look at this.

"Are you talking about findings reported in Kasikis et al 2021 or something else? If you're off on some tangent with results from other material I need at least a reference to know where you've gone. I certainly can't agree that the reason to ensure batch to batch consistency has been removed."

This is the slide I am looking at . Thanks to OP

https://hotcopper.com.au/posts/63211198/single


You would also be aware of the only trial completed by that other mob. The only positive data that could be found was in contrast to cohort A cohort B shows a clinical response at day 3 , unfortunately however this is only reported as a clinical response at day 3 so no more accurate biomarker data was given more over long term response is not given. The response may not have been confirmed by the blood test.(tangent)

So don't you think it likely that Remectemcell also delivers a rapid response? detection by far more accurate biomarker data that has also been shown in correlation
to long term survival ?

Now as I asked you yesterday
Think about the totality of the evedence of efficacy as a Dr that would be treating a child. You have a child that has a bad blood test. Data suggest about a 20% chance of survival . Decision is made for Remestemcell-L to be administered as the product has been deemed safe and the child has more than 3 times the chance of long term survival . I should see a response within 3 days and blood test will confirm that response at 7 days , that will confirm that my patient is very likely to survive long term. Would you not think to take action ,report and demand another batch of Remestemcell-L if a response was inadequate?

Can you now understand ? The reasons for the FDA concern over potency assays have gone from been significant at time of the ODAC meeting to now a fairly minimal concern .