TSN 0.00% 1.0¢ the sustainable nutrition group ltd

trading today, page-49

  1. 1,858 Posts.
    I vaguely recall they extended the number to 390 from the original 350 to make the trial more statistically robust.

    Back in 2010 ACL wrote,
    "After consultation with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), both regulatory agencies indicated that the successful completion of the planned single pivotal Phase III trial will be sufficient for registration in both regions." - 12/7/2010

    That suggests that PFS is OK as an endpoint.
 
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