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Re: WeeZuhl post# 260714

Saturday, 07/08/2017 2:03:56 AM

Saturday, July 08, 2017 2:03:56 AM

Post# of 402160
Can you please explain what this means in blue below?

The mean Tmax of SequestOxTM was 4.6 hr with a range of 0.5 hr to 12 hr and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr with a range of 0.5 hr to 12 hr.

1. How far off are we?

2. Does this mean our product takes 1.2 hours longer to kick in?

3. Why didn't he include in the PR how much quicker the new SequestOx was released into your system as opposed to the old formulation. Looks like the PR just compared new SequestOx to the comparator.

4. Why is Nasrat speaking as if we can still get an approval and it's not as clear cut yet until we meet with the FDA? .........."We were hoping for better and more decisive results for the reformulated immediate release version of SequestOxTM",

Thanks.




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