I can't reconcile the Phase III enrollment data that the company has recently provided in the slide show originally created for the BTIG Virtual Conference. For instance:
slide 2: step 2. 300 patient for Phase III study (plus 200 patient BET study)
slide 7: target completion of Phase III enrollment in Q3
slide 10: "Lenzilumab shown to be safe in clinical settings following administration to 125 patients in multiple indications (including severe respiratory conditions and leukemia) with no serious adverse events..." which includes the 12 patient Mayo IND/CPU study.
This is confusing. I can only assume that the clinical results mentioned in slide 10 were dated, and due for an update. But on the face of the data as presented, we have gone from early May until almost early Sept and only enrolled 125 of the 300 patients needed (almost 4 months), and yet we anticipate completing enrollment of the 300 patients by the end of Q3, which is in about 4 weeks.
The "bullet points" of the slide show were nice, but I think they may have been a little too abbreviated. Besides the 125 patients for whom safety results were known, how many other patients may have been in that study, but data was not yet sufficient to report their progress?
I'm going to accept what management said in terms of a Q3 completion of enrollment.
So the question becomes, will the BET be completed before then? I think they really only need 100 patients treated with lenz for that trial (since the additional 100 patients will be treated with a placebo + remdesivir). So you may be right, and the BET will be completed ahead of our in-house P3.
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