Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[bhp1rtp]

What do we know?

The warning letter came out in December 2013.

Prior to December 2014 several studies investigating the effects of Anatabine on the human body were conducted and the thyroid study was released on line (print edition was due in January).
The supplement Anatabloc was being sold and consumers were reporting amassing results.

Prior to December 2014 the FDA was not commenting about Anatabine.

In MY Opinion (IMO)
The FDA was shocked that a supplement could show the results that Anatabine was producing.

IMO
The FDA thought this is the real deal. Anatabine is the gateway to the Alpha-7 nicotinic acetylcholine receptor in a non addictive manner.

IMO
The FDA believes it is in the best interest of the public that Anatabine be classified as a drug. The reason the FDA might think that way is that if Anatabine is a Drug than Doctors will be able to monitor the use of Anatabine and report on both the positive and the negative results of using Anatabine. In the long run this information would be very useful to mankind.
What we don’t know is what the FDA does next. In my mind we will wake up some day to the answer just like the news we discovered on Friday morning.

IMO there are only 4 options left for the FDA
1. Accept the IND and start phase 1
2. Accept the IND and start Phase 2. This will happen if the FDA considers the human studies already conducted and the safety profile established in the studies.
3. Accept the IND and start Phase 3. This could happen if the FDA accepts the results of any and or all the Clinical Trials. www.http://clinicaltrials.gov/ct2/results?term=anatabine&Search=Search and all the information RCPI has provided the FDA. We do not know what RCPI has provided the FDA. We do know they conducted the 3 clinical trials listed below, The Thyroid study was published the information from the others studies may contain valuable information that we do not know about. I assume they have been conducting follow-up on the thyroid and CRP participants. The FDA may now have that information also.

The 3 human clinical trials are

Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP
Effect of Anatabine on Elevated Blood Levels of C-reactive Protein Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease

4. Determine that Anatabine is meeting an unmet public need. The results of the human studies and the years of research conducted on Anatabine and Alpha-7 nicotinic acetylcholine receptor are so conclusive that it is in the public interest to let doctors prescribe the Drug and monitor the results.

IMO we will wake up some morning and know the answer.

The question is will it be tomorrow or will it be in the distant future?