The FDA is very comfortable and has has not required HA to be a standalone control arm being because it's an experimental agent.
They need to speak to the Doc because in his view they are all still wrong ? lol
I cringe at the closing remarks by SI every time he uses the phrase "we will update the market shortly" .... I would have thought that the PI insurers would have pulled him up on that and perhaps suggested something like :
"we will update the market in due course"
All in all the presentation was good and the 3 year data was impressive and so were the KOL's presentations but let's face it, you don't put a referee on your CV that is not going to say good things about you so I expected they would have great things to say about Rex-L ?
I see someone is too busy to listen in or ask questions but has plenty of time to post on HC ... laughable after this presentation that he still claims to know better than the FDA/OTAT, Mesoblast, Grunenthal, KOL's etc etc .....
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