RE:SOCpatience69, yes the company is using the term
Standard Of care. But maybe not in the same way you might think.
In the last Corporate Presentation page 10, Theralase said '' Radical Cystectomy is the current standard of care for BCG -Unresponsive CIS.
So Standard Of Care mean
Radical Cystectomy. On the same page Theralase said '' There is a critical need for effective bladder-sparing therapies for BCG -Unresponsive NMIBC.
BTD approval is for when there is a Critical Need. Up until now Theralase has proven without a doubt with Ruvidar data, that they could fill that Critical Need.
Critical Need also mean that no other FDA approved treatment is available for these type of patients(patients that only choice is Radical Cystectomy).
BTD approval of Ruvidar for this Critical Need(Radical Cystectomy) definitively looks good.
patience69 wrote: Just curious. Has anyone else noticed a little change in the wording over the last couple of months. Maybe its me & my glass half full attitude but it seems to me that since these discussions have been going on with the FDA lately concerning BTD I have seen the term "standard of care" come up a bit. I can't see the company dropping that term randomly unless they have reason to believe that it is a possibility