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AVII77

05/29/18 11:36 AM

#174303 RE: MI Dendream #174229

Final randomization seems to indicate that the last 30ish patients enrolled after the halt were put on treatment only rather than randomized to placebo. This confirms in my mind that the halt was due to an efficacy signal and regulators required randomization to placebo to be stopped. The trial continued but it was no longer ethical to randomize patients to the inferior arm.


Interesting observation.

While I agree it appears the last 30ish may have been put on treatment (not randomized).....my thinking as to 'why' is different.

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biosectinvestor

05/29/18 11:42 AM

#174309 RE: MI Dendream #174229

Agreed. I think given that and previous things I’ve noticed with regard to regulatory dispensations, I have little doubt.