Replies to post #79524 on Intellicell Biosciences Inc (fka SVFC)

[karlm34]

Let's not forget the FDA has the final say on what SVFC can and cannot do. Refer back to the warning letter they were issued on 3/13/2012. http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm297245.htm

Then refer to this general stem cell warning issued by the FDA: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM286213.pdf Pay close attention to paragraphs 5 and 6 under regulation of stem cells, particularly the following two statements by the FDA: "Investigational products undergo a thorough review process as the sponsor prepares to study the safety and effectiveness of the product in adequate and well-controlled human studies (clinical trials)." and "FDA also requires that there be sufficient data generated from animal studies to aid in evaluating any potential risks associated with the use of these products."

In no way am I being negative about their products, just saying that the process is a lot more time consuming and costly than what people are aware of. Animal studies can run millions of dollars and take years to complete.

To help you better understand the process, you can start by reading about the preclinical process in the following FDA guidance document: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm376136.htm ; and in order to receive an IND (with a few exceptions (see below), you need preclinical information).

There are a few cases in which you can apply for special INDs (Treatment IND and Emergency Use IND), but these cannot be used for the clinical trials needed for approval of the products. These INDs are on a case by case basis and require a separate IND for each patient. This is most likely the path they used in the cardiac patient and the key to that is they stated in the article the treatment was a last resort.

They took the first step in the process by filing the pre-IND. And they should now, hopefully have a better understand what they need to do in order to avoid future warning letters and get a product to market.

Lastly, it has been stated in here that the SVFC products being proposed are not drugs, again, that information is not accurate. Keep in mind what SVFC is claiming and how the law defines a drug: The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. Refer back to the warning letter requiring SVFC to file INDs.

This information is of course, in my opinion, and prepared by my research and experience in dealing with FDA regulations for the past 10 years. Hopefully it helps some people with FDA questions.

And yes, I do have shares of SVFC, and have for a while because I believe if they can get through the FDA process and clinical trials, they will have some important products on the market.