Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

With regard to the nutritional supplement business, the company filed a New Dietary Ingredient Notification (NDIN) in June 2014 as a measure to address certain provisions in the December 2013 FDA warning letter. Although the company does not believe that an NDIN is a prerequisite to the lawful marketing of the nutritional supplement, the NDIN was voluntarily submitted to provide the FDA with preclinical and clinical data concerning the supplement. 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. However, the company does anticipate these actions will bring the FDA warning letter matter to a close.

The paragraph says it all, but doesn't say enough. If NDIN was filed in June, and they have not received FDA's response, how do they know they have a review to complete? Sounds like the FDA called the company and explained they were denying their NDIN request without more information, and the physical letter is forthcoming. This is purposely not transparent, and concerns me.

Next is the 'voluntary' removal from the retail market. Sounds to me to be analogous to an individual being forced to resign for the matter of appearances. Once again, not transparent.

The last part -- "the company is also voluntarily suspending its sale of CigRx® and Anatabloc® until such time as the company can ...review [how the] nutritional supplement business may affect the company's drug development program" -- is what concerns me the most. If the company makes a voluntary choice to halt supplement sales permanently, or not pursue the FDA until the supplement is returned to the shelves with the resumption of marketing priveledges, then I will have lost all faith on the product and company. It shows, among other things, their interests are not aligned with users, who believe that anatabloc provides a benefit to their health and well-being. It shows that they will put their perceived business advantages ahead of the health benefits they purportedly feel anatabine provides. It says greed trumps good.

It would be, to say the least, very unethical. But that would only be the case if they feel this compound works. If they don't pursue getting the supplement back on the shelves as quickly as possible, that truly says it all.