A CR may be possible - I'll give you that!
But, you have to let go of the RCT for kids.
I'm getting the info first hand, and you have to be there to ask the question and get the response...
Let's put it in another way that may help you to understand...
The FDA were not shy to say RCT required to show evidence of effectiveness of Ryoncil in CRL#1 did they?
So, why didn't they mention RCT again in CRL#2? Because, the FDA have gone passed it - and have now acknowledged that the Study 001 was well constructed and executed trial - it met its endpoints. So no more talk about RCT for kids!
Posting it again and again - does not make you right on this point
Ann: CEO Presentation to 2023 Annual General Meeting, page-34
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