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Re: Protector post# 244554

Saturday, 12/05/2015 7:11:44 AM

Saturday, December 05, 2015 7:11:44 AM

Post# of 345964
CP, I have searched all the transcripts from PPHM CCs (plus 2013 ASM) and cant find Shan saying anything about enrollment being of a bell curve type.
On the contrary I think he considers the possibility of a hokeystick type enrollment

This is from Dec 10th 2013
George B. Zavoico - University of Virginia
And finally, with regard to the duration of enrollment you said too -- and I haven't looked at the clinicaltrials.gov, so forgive me if it's already in there. I imagine the overall survival look is about a year. So with a 2-year enrollment, if you meet that, then top line results in about 3 years then?

Joseph S. Shan - Vice President of Clinical & Regulatory Affairs
Again if it is sort of event driven. So that's, like Steve mentioned earlier, a function of enrollment if the enrollment curve more of a hockey stick or more of a flatline -- Straighter line slope, then that will determine when we think the number of events necessary will hit. But it's really hard to say right now when exactly it will reach the final number final of events and of course, the interim analyses are another factor.

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and this another SK's comment
Steven W. King (9-9-2014)
Yes, I think we haven’t given a lot of additional details other than you know the fact that again that trial is also getting up to close to full steam as far as number of sites involved in the study and it most critical with of course once you get all the sites up running and that’s when you reach the maximum enrollment rates. So at this point, I mean we are simply saying that we are on track for the initial estimate less than two-year enrollment and can if we first start to deviates significantly when – other for that will let everyone know but at this point we feel comfortable that we are on track.


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Do you remeber when Shan talked about the bell curve enrollment type?
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