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Re: vanwes1 post# 258394

Friday, 05/26/2017 11:37:58 AM

Friday, May 26, 2017 11:37:58 AM

Post# of 403349
I understand your frustration. I really do. I think you are looking a little too deep here. The exclusions have nothing to do with bioequivalence. Simple criteria is simply not being met to have data included. This could easily be people people simply not taking the pills at the right time, eating when taking the pill, perhaps some tried to inject it, etc. With this small of study we want to ensure the criteria is met so we can analyze the data appropriately. If data collected is bogus, the analysis will follow suite. The only red flag for me is that we have another freaking delay. Camargo is ensuring exact execution of the subjects inclusion/exclusion criteria that is holding up the process.

Now I personally think that this will also delay the SequestOx submission later this year to move to Q1 2018 assuming all goes well with BE & dosing studies.
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