Stem Cell Therapeutics Corp. has announced that it has received the minutes from the FDA meeting of December 20, 2010. The purpose of that meeting was to present data from the NTx®-265 Phase I and Phase II studies to obtain medical, safety and statistical input about a planned pivotal study design.
Management is encouraged that the FDA minutes confirm their understanding of the discussions during the meeting.
Management is currently reviewing the minutes and incorporating them into the ongoing planning and design of another NTx®-265 trial. The next steps for this pivotal trial will include finalizing the protocol, planning the execution of the trial, determining appropriate financing and evaluating feasibility. Further details about the planned trial will be announced once they are available.
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