the choice of russia to host the clinical trial (or 90% of it) is reckless. no pharma trusts russian clinical studies for a myriad of reasons. so, the bigger question: if ipix gets a decent result, will regulatory authorities from the west, or pharmas that may partner, request a larger phase 2 or phase 3, simply because they don't trust the results. put it in this scenario, a bad one (that could still be spun): the US sites deliver bad results, the russian sites deliver pretty good results. Ipix doesn't share the us site outcome, just discusses topline for the russian site outcome or rather overall outcome because the us sites are such a small % of total patients. but, the problem for regulatory and pharams is they WILL dive into the the site differences, and if the discrepancy is huge, a massive red flag will go up, which may put ipix back in the post phase 2 brilacidin what do we do now doldrums, which is entirely management self-inflicted gun shot wounds for choosing a country that is highly corrupt and no one trusts. the bigger question is: why did ipix choose russia? what is it that was the great draw there over other much more common and cheaper global trial destinations (australia, latin and south america, mexico, etc). why russia? why risk an already small trial data set hell bent on one country alone that no one trusts and for good reason? why?
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