Urocidin as 1st line drug I did a historical search on all the trials on Urocidin. According to : https://www.drugs.com/clinical_trials/bioniche-presents-mcc-data-siu-world-uro-oncology-update-santiago-chile-6298.html
P1 and P2 : "the results of Phase I/II clinical studies with MCC, which involved 130 patients with Carcinoma in situ (CIS) high grade bladder cancer, with or without papillary lesions. The majority of these patients (62%) had been previously treated with bacillus Calmette- Guerin (BCG)."
P3A and P3B : As we know, all the patients are refractory to BCG.
"The refractory to BCG indication was given Fast Track designation by the U.S. Food and Drug Administration (FDA) in April of 2006."
We do not have a Fast Track designation for 1st line use from FDA. We need a trial to compare Urocidin directly to BCG. All the results have only implied Urocidin is safer and likely to be as effective. But there is no direct comparative proof. Would Canada Health accept this implication as a basis for the "Notice of Compliance with condition" (NOC/c)? That is a crucial question.
Perhaps when Graeme mention the NOC/c from Canada Health, he was refering to the use of Urocidin as a refractory drug? We ned to clarify this on Jan 10th also.
BTW, we shuld also ask how long is the term of the recent loan and if there is any prepayment penalty if we manage to pay it off early to avoid the revenue raid.