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Posted On: 10/04/2021 1:02:13 PM
Post# of 36569
Re: Zolis_onkel #32446
I agree w Zoli on the clinical trial timeline not being grossly affected by the holidays.
On the other 2 points, however, I had a different understanding. Feel free to correct me if I'm wrong, as I'm going off of memories that are fading with all the elapsed time!
My memory tells me that there would only be one set of trials - in the US, trying to have adequate data for use in China and wherever else.
After the trials would be when the path diverges. The China consortium would take that data to their FDA, we would take it to our FDA, etc.
So the post-trial data availability would really be the point where China could potentially accelerate the timeline relative to the US, not the IND approval/trial commencement.
Again, that's what was in my memory bank... others may have better sources than that ; )
On the other 2 points, however, I had a different understanding. Feel free to correct me if I'm wrong, as I'm going off of memories that are fading with all the elapsed time!
My memory tells me that there would only be one set of trials - in the US, trying to have adequate data for use in China and wherever else.
After the trials would be when the path diverges. The China consortium would take that data to their FDA, we would take it to our FDA, etc.
So the post-trial data availability would really be the point where China could potentially accelerate the timeline relative to the US, not the IND approval/trial commencement.
Again, that's what was in my memory bank... others may have better sources than that ; )
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