I have a few question and hope the expert here can help me out.
1. Targeting 400 patient and now have 322 since December 2015. So 78 more needed in the time of 3 weeks. If their can't meet the 400 patient target are there still announce the trial result or not?
2. Is 400 patient is the criteria for the FDA approval? If no, than no worry about question 3 & 4.
2. Without the 400 trial patient by the end of this month, is that means TK have to delay the FDA application or not?
3. After reach 400 patient by the end of this month, aren't the hospital need time to monitor the patient?
This is what I don't understand. Please advice and thank you in advance
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