Isotechnika Pharma Inc IPHAF

RE: I am also a doctor and 10 year ISA veteran

[WASKERWISK]

head to head is the cyclo psoriasis trail results for which are expected in Q1 09

as I mentioned in a previous post though, the primary endpoint of this study is first to show efficacy over placebo and the secondary endpoint is that it is non inferior in efficacy at .4mg/kg to cyclosporine at 1.5 mg/kg - i.e. to show that the lower and supposedly safer dosage of voclosporin works just as well as the higher dosed and supposedly more hazardous cyclo -

what I don't know, and maybe someone (sensible) out there does know, is whether the comparative safety profile with cyclo will fall out of this study or whether the design of the study will obscure a scientific assessment of the safety advantages - if the results do not show superior safety over cyclo then I don't think the market will much care what the reasons are nor will it be satisfied with some kind of explanation that in looking at cyclo problems one should be looking at historical difficulties with cyclo over multiple studies and not THIS study (i.e we could get snookered if, for whatever reason, we happen to have a health bunch of cyclo users who tolerate it well)

Also, I am not 100% sure that if there are safety advantages they would have had time to manifest themselves;  my limited understanding is that the impact on kidney function is fairly soon in the treatment but maybe not - hopefully so because otherwise that will just compound the difficulty in showing safety advantages early on