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WeeZuhl

08/09/18 9:27 AM

#36145 RE: Samsa #36144

Keep up.




weezhul, again you make unsubstantiated claims. no one can say at this time if they will pass the oral abuse labeling standard. IPCI claimed they do. Naturally, I can not comment too much on what they prior claimed but they did claim they are oral abuse deterrent. Your slim reference to Odidi's claim that it can be chewed like bubblegum as a reason for not passing is immaterial. It does not matter if it is chew-able or not to be oral abuse deterrent, it comes down to the amount of opoid that is extracted. which none of us will know until they conclude all the studies will we?







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.