Short Ideas

[CHM_760]

CTIX: I've spent some time trying to educate myself on the newer FDA guidance for ABSSSI trials. I found this paper, which helped me to better understand the difference between the primary endpoints for the Polymedix and the Cellceutix Phase 2 trials.
http://paperity.org/p/42787973/fda-guidance-for-absssi-trials-implications-for-conducting-and-interpreting-clinical

Although the paper indicates that the >20% lesion reduction standard is less subjective than the old guidelines, I now understand your comments about the shorter treatment period. That won't fly with the EMA apparently. However, don't the new FDA guidelines include much stricter enrollment criteria?

Also, the TRSAE reported in the Phase 2a trial done by Polymedix were only at the highest doses, correct? I'm hoping that the "lack of transparency" in releasing the full Phase 2b data is due to CTIX saving it for release directly to the scientific community via poster presentation at ECCMID in April or via publication in a peer-reviewed journal.

One comment you made earlier was your concern that the FDA would try to "deep six" the defensin mimetics technology for antibiotic use. Without going into why you've had such a concern in the past, wouldn't the new QIDP designation allay those concerns?