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Re: staccani post# 1269

Thursday, 09/21/2017 1:22:09 AM

Thursday, September 21, 2017 1:22:09 AM

Post# of 2099
Gr8 is correct, the interim was cancelled in favor of the DSMC review. Call the DSMC event whatever you want, but it does not mean that the originally planned interim - as communicated in Dec 2016 - was not cancelled. FYI, many on this board looked at what is under the purview of DSMC and it appears that futility can be a part of safety criteria. For example, if drug is clearly not efficacious, ethics might call for early termination so as to not give patients "sugar water". (https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf)

Also, this trial has changed several times based on extenuating circumstances. I do not think anything happening makes perfect sense to anyone, except oren... and now apparently you.

Clearly rapid enrollment impacted the cancelled interim, however, I am not convinced that is the end of the story. Remember, these guys spent a good deal of time with FDA at end of last year hammering out modifications to interim. In Dec16/Jan17 they adjusted plans due to increased enrollment, so why were they surprised by their projections a second time in August?

Also, you brought up good points about timing of enrollment. If mOS has truly been reached, then a look at the interim data would be very telling of the primary endpoint (OS).

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