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5TOP

09/16/16 9:57 PM

#5956 RE: Amatuer17 #5954

They have been enrolling for a year now with a 2 year primary completion target. They *should* have 150 enrolled by this point. It would be UNBELIEVABLE if they didn't have 30 patients enrolled by now.

As far as the clinicaltrials.gov status goes, the change was made back in July so it must be an error. And the 300 patient size obviously still needs to be updated to 150.

My guess is that if the FDA agrees to reduce the number it will be to whatever we have currently enrolled, certainly more than 30, and we will get primary data almost immediately and completion 24 weeks later, 1Q 2017.

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misiu143

09/16/16 10:23 PM

#5957 RE: Amatuer17 #5954

Amatuer17- I didn't look / read any place , this is from the last conference I heard myself , and I am paraphrasing now.....

He ( Dr P ) think that FDA will reduce # of patients for P3 adjunct, and than they will finish the P3 adjunct study in first Q of 2017.

This is what he said , nothing more or less......( personally I think nothing more was needed )

But if you have more questions , you should e-mail to them.

I must say I have no more questions, let this study finish !!!!!!