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Re: jour_trader post# 212549

Thursday, 07/14/2016 6:52:56 PM

Thursday, July 14, 2016 6:52:56 PM

Post# of 406433
I agree. First approval. However given the cross referenced other opioid companies who HAVE obtained approval with labeling and seeing data that has overwhelmingly showed ELTP technology to be stellar. I think we can say proof of concept is almost a given at this point. No ADCOM! Priority review! As of yet no CRL. The CEO stating in the CC he and his team has answered ALL the FDA questions they have had.

But yes. Approval is needed "officially". However I am fairly confident with the above mentioned "coincidences" we will receive approval with best labeling.
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