Thursday, August 09, 2018 9:27:33 AM
What I have repeatedly claimed is that it will not pass chewing label because it is PEO-based, and no other PEO-based drug has ever been given the chewing the label. This is not an unimportant point. Collegium has the chewing label. No new NDA's will be approved without it, and Rexista, which can be chewed like bubblegum, will definitely NOT be the first.
I shouldn't have to mention that the company has said a lot of things, including that they had conducted all the necessary abuse studies, when they hadn't conducted any. It's pretty rich to say I'm making unsubstantiated claims because the company says otherwise. Had they done what they said they did, we would know for certain they are not going to qualify. It is very much to their advantage to continue to lie, delay, and obfuscate, so that suckers continue to believe the fantasy.
Call on God but row away from the rocks.
-Hunter S. Thompson
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