Thanks for the reply, much appreciated.
Actually, the protocol is for a 60-person study, double-blind, PE measurements at 100 days post-treatment. Management stated on the October call that the FDA would convene an IDMC after 10 patients finished treatment in order to determine essentially if it was ethical to continue treating with placebo, or if they should make it a single-arm trial. At the time of the call, they had nine patients who were enrolled - I believe all had finished treatment - and they were continuing to enroll. As I noted, your time frame COULD be about right.
And I hope that it is!
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