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Re: BlackDoggie post# 17580

Friday, 10/13/2017 6:42:11 AM

Friday, October 13, 2017 6:42:11 AM

Post# of 233144
Well - fda was not sure about numbers so they had requested meeting and company knew about it - as such the PR issued about the meeting had tea leaves about delay

So the revised protocol reads as
- increase of no of patients from 30 to 50 - an increase of 66%
- interim analysis at 40 patients - was not part of the original requirement
- total 300 patients for safety - original was 100 including mono

All this means additional delay.
Proved again that when fda asks for face to face meeting is never good.
Well I was negative about the meeting but right.
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