If a “clinical” project fails to go into patients by year 2, and was required for 50% clinical, what happens?
In order to be selected as a Specialized Center, an applicant must demonstrate to the review panel that the clinical projects proposed can begin clinical studies by the beginning of year 3. However, it is realized that other factors could intervene while the studies are being carried out. For example, if the FDA places a regulatory hold on all new cell-based therapies while additional safety studies are carried out, then all SCCT clinical studies could be delayed .
