I believe Leo receives patient reports as a sponsor. Someone who was a patient in a trial confirmed that the site investigator sent a report to the sponsor on his status weekly.

Here's what Leo said two years ago,

"We have also identified inflammatory gastrointestinal disease (ulcerative proctitis) and inflammatory skin disease (hidradenitis suppurativa) as indications for treatment with Brilacidin or our other HDP mimics. The Company is preparing to advance these programs upon review of preliminary results in the oral mucositis trial ."

http://www.ipharminc.com/press-release/2016/1...er-30-2015

So where did he get the preliminary results? From the patient reports IMO.

As Karin pointed out earlier,

"In recent months, the number of study sites in the OM trial has been increased and enrollment is accelerating. Cellceutix has moved through this trial methodically, waiting to increase trial sites to conserve capital until research provided additional support to the potential of the anti-inflammatory and immunomodulatory properties of the drug candidate ."

http://www.ipharminc.com/press-release/2017/4...0mucositis

I think the reason to add more sites for P was similar to B-OM. We shall see.