RE:RE:RE:RE:RE:Phase 0digitel asked, "Does the risk involved in non-human primate testing now stand before phase 0 testing?"
He further asked, "...isn't biodistribution a significant risk factor and that also explains why BTI is now testing it?"
Yes, it could be considered that It's possible for NHP biodistribution tests to reveal negative results. However, given the known excellent distribution of human xB3 constructs in mice, it probably is not a "significant risk" as digitel suggests.
Doing the NHP studies is more than just a formality. Obviously, the company has every reason to believe that the studies will be successful, but I suspect successful completion of the studies could provide the company with more accurate scientific information about expected distribution and other elements of drug delivery in humans. This type of information from NHP studies is considered to be about 97% predictively accurate with respect to results in humans and could aid the company in its application for human trial approval.
If the NHP studies raise some problems, I would think that the first order of business would be to analyse the study's design and execution. Bad results would be wholly unexpected by us all, given the distribution and efficacy results that we've seen to date in studies in lesser mammals.
But we understand. Raising the spectre of failure is prudent. The risks are detailed, afterall, in every MD&A ever produced by the company. I'm sure that all of the new, high-powered, executives and board members studied the risks before they signed up. And yet, they have signed up. So you can weigh digitel's opinions against the opinions of these new people, and decide for yourselves how you might want to play this.
jdstox