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Tuesday, December 05, 2017 12:53:35 PM
Doc WeeZuhl You obviously have exceptional ability to micro-analyze the FDA Tmax historical data for Roxicodone and the consequences on SequestOx Tmax comparison. Since you have been to various AdCom meetings with FDA officials presented are you able to use your vast knowledge in presenting your findings to the FDA. Would the FDA grant you an audience to hear your support of SequestOx?
I actually spoke with Dr. Sharon Hertz at the Rexista AdComm. I had presented a couple dozen slides about the safety concerns regarding the substantial quantity of the mitochondrial poison blue dye #1 that would be given to Rexista users 2x/day forever. After the vote, when it was all over except for the crying, Dr. Hertz came over to me and introduced herself and thanked me for my presentation. I told her she was like a rock star in the ADF world, and it was an honor to meet her. We chatted for just a minute, and at the end of our conversation, I mentioned SequestOx. It was soon after the reformulation BE study results came back, and I mentioned the results were not as good as we hoped. I told her I knew she wouldn't be able to comment, but I hoped it would get some consideration even though it was slightly out of bioequivalence range on the fed tmax. I told her the benefits of the ADF far outweighed the risk of inadvertent overdose. She smiled and shook her head, then told me to have a safe trip home. That was the end of our discussion.
Call on God but row away from the rocks.
-Hunter S. Thompson
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