Evaluate, to answer your question about enrollment, I attended the annual meeting and asked Linda to give us a better number than "over 300". I suggested 325 or 340. She laughed and said "we're already close to the total number."
So you figure it out. I took it to mean they still needed a few more patients to call enrollment complete. A few could be 2 or 4 or 10. That's as much as she would say.
They have told us that a regulatory board is looking at information verifying that each patient in the trial met all trial requirements. To me that sounds like the FDA is verifying facts before making a decision on this treatment.
Any other thoughts, please share. I go back to Flipper's due diligence and other posters who found a case or two where the FDA stopped a trial for effecacy without the company requesting it.
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