Part1
There is a risk that the FDA may not accept the data from the two previous trials. In that case, we may be required to conduct a Phase 1 or a Phase 1/2b clinical trial rather than the planned Phase 2b clinical trial, which may result in additional total costs to us and/or delays in the regulatory review process and any future commercialization and marketing, if regulatory approval is obtained. It is not known whether the FDA would be likely to reject the use of such clinical data due to the time that has elapsed since such trials were conducted or because the clinical trial material for our proposed Phase 2b clinical trial is slightly different from that used in the earlier clinical trials as a result of cloning the cells used in the earlier trials and certain modifications and improvements that have been made to the Cell-in-a-Box® technology since the time of the earlier trials.
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