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Tuesday, October 31, 2017 6:47:41 PM
The fact that patients are living longer, and IMHO those randomized to treatment had taken much longer to even event than estimated, means the study went on, and on, and on. As Lind L, stated that's not necessarily a good thing. Funds dried up and manufacturing capacity sat relatively idle, except for Expanded Access Program use.
BTW - expanded access programs are regulatory approved and intended to be used to speed access to promising drugs.... would that be considered good news if say 100+ patients were allowed access outside the p3 study while we waited for people to event?
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