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Re: None

Tuesday, 09/02/2014 2:01:51 PM

Tuesday, September 02, 2014 2:01:51 PM

Post# of 30990
So when do we find something out? RCPI update from 3 weeks back suggests that FDA will provide a response to NDIN...when?...and is the data that RCPI provided the same as it has to provide for the "objections and/or missing information" that FDA requested for IND? Still lots of questions...but seems that soon RCPI should be advising on specifics. What obligations does FDA have timeline wise for the NDIN?

From previous Rock Creek update:

"In addition, the company is also voluntarily suspending its sale of CigRx® and Anatabloc® until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program."

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