Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

Edit: McDonnell used the term "safety issues" in his resignation letter. Is there prior public documentation to suggest that safety was a/the purpose of the hold? I haven't been able to find any:

From the Sept. 30, 2014 10-Q (http://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=9891585&type=HTML&symbol=RCPI&companyName=Rock+Creek+Pharmaceuticals+Inc&formType=10-Q&dateFiled=2014-11-10&cik=0000776008):

On August 25, 2014, the Company received a response to the NDIN from the FDA. The letter indicated that the FDA considers anatabine, a principal ingredient in these products, to be a drug, because anatabine was intended to provide anti-inflammatory support, and was previously authorized for investigation as a new drug. Based on the FDA position, the Company permanently exited the dietary supplement business for anatabine in the United States (“U.S.”). However, the Company will continue to seek opportunities to license the product for overseas markets. All of the Company’s revenues, cost of goods sold, marketing and sales, inventory and manufacturing machinery related to the dietary supplement business were accounted for as discontinued operations effective September 2014, since the Company exited the U.S. market. The FDA notified the Company in a close out letter dated October 21, 2014 that the FDA has completed it’s evaluation of the Company’s corrective actions in response to the warning letter issued on December 24, 2013. In this notification the FDA stated based on it’s evaluation, the Company has addressed the putative violations in the warning letter

Regulatory Hurdles; IND or European Equivalent Process

The drug development business is highly regulated, and requires the filing of an IND application (or the European equivalent) and a Clinical Trial application (“CTA”) related to any new pharmaceutical products we intend to introduce. We filed an IND application in June 2014, however, the FDA has issued a clinical hold on the application. We are currently complying with the FDA’s comments by undertaking additional preclinical studies which address those concerns. We expect to complete those additional studies during the fourth quarter of 2014.