"22nd Century Group (XXII -1.3%) engages a major contract research organization (CRO) with extensive experience in tobacco exposure studies to help it with certain regulatory activities at the FDA's Center for Tobacco Products (CTP) to support its development of modified risk cigarettes."
"The CRO will be deeply involved in the interactions with the agency. It will be responsible for the preparation of meeting requests and meeting information packages to be submitted to the CTP, including protocols for clinical exposure studies, and it will conduct the studies themselves. It will also assist XXII with the execution of CTP meetings and follow-up regulatory activities."
This is not like the development of a brand new drug, so no I wouldn't expect it to be that type of timeline with p1, p2, p3 and so on...
The CRO will be interacting with the CTP presumably for guidance. There will be some type of "clinical exposure studies" read clinical trial of some type... we will know more regarding timelines once details are revealed following meetings with CTP officials... the trial design information for example will give us some insight into length of trial, efficacy objectives and so on... at this point it is just way too early to tell... but no this is not a new drug application which must run the entire gauntlet of p1,2,3 trials before seeking approval... jmo
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