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Friday, March 01, 2019 12:33:10 PM
If Elite's Tech can be defeated, where does that leave SequestOx and the complete ART Opioid pipeline?
IB, I think it is important to realize that even with the extraction issues I showed in my earlier post, Troxyca was still given a greenlight at AdCom. It was 9-6 in favor of IV ADF label and 9-6 in favor of approval, and that is with the intact pellet extraction problem that SequestOx should not have. Nonetheless, Troxyca did not sail through, and that is big boy Pfizer. Nasrat is no dummy, but he knows that at least some members of the Adcom seem to be (based on regular asinine comments in the press after votes). As with every AdCom I've ever witnessed, if the panel wants to find a reason to shoot it down, they will, and if they want it to go through, they are equally capable of overlooking glaring deficiencies. Usually, the FDA sets the tone, and the committee members pick up on it and run with it. Nasrat knows there will be extraction problems, and I'm sure that will be a part of his decision-making formula going forward.
Call on God but row away from the rocks.
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