This is my humble opinion and, to some extent, an educated guess based on my years of experience in the pharma business... the below quote from yesterday's PR says to me that trials will most likely not begin next month or within the next 60 days perhaps. That most likely a second (or third) round of Q&A will commence within the next 30 days. I do not believe the FDA'S demands for proof of efficacy will be met in this round. This is not reflection on Koos or BMSN--this is purely FDA politics and BS.

Keep accumulating.

"We are pleased with the responses that we have provided to the FDA and look forward to initiating our clinical trials," stated David Koos, Chairman and CEO of Regen BioPharma. Although it is possible that a second round of comments may be issued, we feel this process is extremely useful to creating a clinical trial that is optimized for safety and detection of efficacy."