If memory serves, PH has used the term seamless design for the AML trial. Seamless indicates a merging of trial phases, with an interim look, used to speed development and lower the number of participants. The same operational processes can be used pre and post look (but having different data subsets) or the data from the pre look can also be used post look. I assumed that the latter case was the case here and there would be some midway look but that the whole data set would be used for approval, assuming the look data (and final data) were good on safety and efficacy. I don’t know stats well enough to understand what this type of design does to the data and/or thresholds for stat sig, etc. The “potential” aspect of the trial could mean, in my mind, that if the “look” data is not positive, the trial might be stopped completely and they’d be done with AML or they might dig in on all the data, finish this trial, but launch a completely new (probably pivotal) trial with something different (higher dose or whatever). If the data is good, they finish the trial and use it for application for approval (i.e., it's pivotal). That's how I read the language in the 10-K. As I look at clinicaltrials.gov, there is nothing to indicate this is the approach, but there is nothing to show it’s not, except for them calling it a phase 2 (and the number of participants being relatively low). It’s a question for the company/PH I guess, but it does seem like it is, in fact, a potential pivotal trial (rightly understood).
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