Anatabine development: Very unique in its development aspect. Actually Brilliant. star has run human clinical trials without an IND. How is that possible? Must not be real...... Not FDA approved trials? Ridiculous. Many folks just do not know the rules.
FDA clearly delineates that you can run human clinical trials with a compound (specifically a nutritional supplement) WITHOUT an IND, if one has board approval and complies with such tenets as "intent to file", testing for safety, etc.. Tenets that star has obviously complied with.
Not having an IND has given the company enormous flexibility, allowing them to run below the radar screen of competitive threat, waiting for patent protection and scientific data, and allows them TO GET THE PRODUCT ON THE MARKET TO GENERATE SALES (small but will begin to grow)
Question? Is STAR going the FDA route w/ their pharmaceutical variant? From a recent STAR filing: "If our clinical trials fail to produce sufficient data to support an NDA, it will take us longer, etc...."
WHAT? They are actually thinking about filing an NDA? Where is their IND? Do you think plenty of data already compiled for an IND. Given their filing from Q4, an eventual IND would make sense. Could we see sufficient data from ASAP Thyroid to jump to accelerated phase 3 And subsequent NDA filing? Plenty of human safety and tolerability data. Does anatabIne inhibit TNFa in humans? SAFELY? (unlike remicade and enbrel). Would not bet 30mn shares against.
Will take a few years to get through the FDA, but think it could actually come relatively fast and furious.
Why? Because Anatabine works!
"Patrick Cox reports that he was given a few prototype e-cigarettes and found that they were "simply extraordinary." -- satisfying as tobacco with no harm. "... anatabine/nicotine e-cigarettes could put an end to ... cigarette smoking."
Star will not make such cigarettes, but could benefit from use of anatabine citrate by BT."
Whatever happened to this? This would be market killer. Some company was testing anatabine in e-cig for Patrick Cox to try.
Dr. Wright brings a wealth of research and drug development and drug-abuse experience to Rock Creek Pharmaceuticals, where he serves as the company's Senior Vice President and Medical/Clinical director. Dr. Wright received his medical degree from the George Washington University and completed his initial training at Portsmouth Naval Hospital in the United States Navy. After nine years of naval service he completed his residency in Occupational and Preventive Medicine, and a Post-doctoral Fellowship, at the Johns Hopkins Medical Center in Baltimore, MD.
Dr. Wright then worked as a medical review officer for the USPHS at the Food and Drug Administration in the areas of analgesics, anesthetics and drugs of abuse. During that tenure he was appointed Assistant Division Director and Acting Director for the Anesthetics, Analgesics and Life-Support Drugs Division.
After leaving the FDA, Dr. Wright served in senior management and research positions for a number of biotech and major pharmaceutical firms, working in the development of novel and more abuse-resistant analgesic medications.