Preparing for a New Drug Application


The past two months have been very active. We have begun final preparations to launch the formal research studies for our upcoming FDA application to begin clinical trials. After much deliberation over protocols and documents, the studies have begun and are off to a great start. When completed, in about a year, the results will form the basis for an Investigational New Drug (IND) application.

In addition, Dr. Klassen was invited to a special meeting in Italy, where an international group of experts in retinal degeneration came together to accelerate the development of novel treatments for these conditions. It was a very stimulating exchange of expertise and ideas, from which new approaches will hopefully emerge.

Finally, Dr. Klassen and Paul Bresge made a presentation on behalf of jCyte at the annual Stem Cell Meeting on the Mesa. The majority of participants were working to commercialize stem cell therapies, so this was a good opportunity to share experiences, troubleshoot challenges and identify new opportunities. A number of corporate representatives met with us, and it will be interesting to see how things develop.

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