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bhp1rtp

01/31/14 12:11 PM

#17254 RE: haysaw #17240

You provided the below Quote:
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As such, the FDA has ruled that Anatabloc and CigRx are adulterated with an unapproved drug, particularly since an unidentified firm had filed an Investigational New Drug application (IND) with the FDA in June, 2012. The sponsor isn’t Star Scientific or Rock Creek because they are still only talking about filing an IND as of their shareholder meeting at the end of last year. When I contacted FDA for information on the IND sponsor, media officer Juli Putnam reminded me,

"The FDA cannot comment on any current/pending product applications. The FDA is only able to provide information on approved drug product applications. Any information on an application that has yet to receive an approval or was denied approval belongs to the manufacturer/sponsor developing the drug (21 CFR 314.430)."
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The July 2012 IND should show in the September 30, 2012 Quarterly report

That quarterly report states Rock Creek is pursing the development of pharmaceutical products that would treat a range of neurological conditions, including Alzheimer’s Disease, Parkinson’s Disease, schizophrenia and depression. However, given the typical long lead time for approval by the Food and Drug Administration, or FDA, of pharmaceutical products, we do not expect that Rock Creek will generate any revenues for the foreseeable future from the sale of pharmaceutical products.

IMO the quarterly report is indicating a general IND to cover a range of neurological conditions, including Alzheimer’s Disease, Parkinson’s Disease, schizophrenia and depression. The new IND's are going to be for specific conditions using the compound S-(-)-anatabine