There will be no FDA approval. They have to have something to submit. They need to run trials, there is nothing that could even be submitted at this time.
MCT-125 patent expires in 2019, that leaves 5 years to run the trials, still needs a phase IIb and then a phase III, those will take 3-5 years and then when they are done there will be no patent protection. Those trials will never happen.
Where did you get the idea that there would be any FDA trials?
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