Replies to post #6370 on US Stem Cell Inc (USRM)

[Gsdubb]

I really think you should contact the CEO with your concerns. I don't want to be the only one talking to the company. Any questions you may have can be answered. Over 25 years of research and clinical trials.
This is older but still relevant:
http://www.prnewswire.com/news-releases/leading-experts-endorse-biohearts-muscle-stem-cell-myocell-therapy-62128022.html

I am sure Bioheart knows what they are getting into with the FDA. The FDA allowed the reduction of patients for the phase 3 and second part of the Marvel due to the safety shown through the bio statistical data of the previous trials. Myocell has a good chance of approval compared to other potentially toxic drugs out there. If the results show similar safety and efficacy, they are good to go.
Also, I have worked with many regulators who interface with the FDA. Some got certified and came out of totally different professions like an English teacher. He was quite successful at getting our medical devices through. The FDA is tough, but if you follow their rules and answer all of their questions properly, you will be granted approval as long as your labeling and marketing of the drug, biologic or device abides by what it was approved for. They are extremely strict about this believe me.

Again, I strongly encourage you to email or call with any concerns and I am sure you will get some answers.

I'm not concerned at all at this point.