No, you haven't shown how long it will take for patients to...

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truss20

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16/01/25

08:54

Post #: 77425208
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Originally posted by Pledge: ↑

"The good news is that:
1. No one knows when either the trial will commence or a label extension will be granted.
2. It would only impact 8 out of 29 sites CYP is recruiting from."1. I've shown you before. FDA approval has been granted. The label extension decision lies in the hands of doctors and patients (and potentially insurance companies, which is highly likely). Doctors like Dr. Joanne Kurtzberg, who is a world leader. The word in that world is out already. Adults with the disease will wait for Cynata and the results of the P2 and then a P3 (via 'the FDA under Marks')? I haven't got a link to show, but I do have a brain. You are not thinking that a P3 won't be necessary, are you?
2. Lithuania and Turkey are not likely to be affected by this Mesoblast inconvenience. Whew!

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No, you haven't shown how long it will take for patients to start being treated under a label extension. It would definitely have been announced by Mesoblast if it had commenced.

CYP Price at posting: 22.0¢ Sentiment: Buy Disclosure: Held
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