New article on the legal battle....
“If you interview the average person, I think you would find that there should be some oversight. If you start to look at this product as being the patient’s own stem cell, how can the FDA claim Regenerative is manufacturing [cells] – they’re culturing them,” Angle told me in response to a question about the agency’s rationale to sue the company on the claim that its manipulation of stem cells is tantamount to manufacturing a new drug. Read more on...http://stemcell-news.org/2012/02/stem-c ... iewpoints/
On one hand, I am really pleased that an authority like FDA or EMA are trying to protect us from reckless practices, but on the other hand I feel that they do not strike a good balance between risks and benefits. Many MS patients can not wait for decades for FDA approval. They have not much to lose. I do not understand why debelatating illnesses like MS ()mainly PPMS and SPMS) can not get fast track designation in general.
I can also not understand why we have to wait for FDA or EMA approval in such cases when the drug is already in use for decades with no side effects, but its efficacy was just noticed in MS. E.g. blood pressure drugs, Viagra or neurohormones, etc. just to name a few. As for stem cells, HSTC has been administered with really good track record for a long time, but no insurance covers it and it is not available in many countries.