The past two months have been very active with the final preparations needed to launch the formal research studies required for our upcoming application to the FDA for permission to begin clinical trials. After much detailed deliberation over protocols and documents of all sorts, the studies have begun and are off to a great start. When completed, in approximately a year, the results will form the basis of what is known as an IND application (Investigational New Drug), which is submitted to the FDA. This approval process is rate-limiting for initiation of clinical trials.
In addition, Dr. Klassen was invited to a special meeting in Italy where an international group of experts in retinal degeneration came together to envision a path forward for the development of novel treatments for these conditions. It was a very stimulating high level exchange of expertise and ideas from which much future progress will hopefully emerge.
Finally, Dr. Klassen and Paul Bresge made a presentation on behalf of jCyte at the annual Stem Cells on the Mesa meeting. This meeting was registration only. The majority of participants were involved in the commercialization of stem cell therapies at some level, so this is a good opportunity to share experiences, troubleshoot challenges, and identify new opportunities in this area. A number of corporate representatives met with jCyte personnel and it will be interesting to how things develop going forward.