Biotech Values

[mcbio]

"demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms[OK p < 0.001, but which doses?] when compared to the placebo treatment arm"


"Both the 300 and 450 mg treatment arms[Here, they are very specific about which doses were p < 0.001] demonstrated highly statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment."

Pretty sure those two sentences you broke out should be read together as they are referring to the same thing. The primary endpoint of the trial is the improvement in rescue-free bowel movement within 4 hours of administration over 28 days of dosing when compared to placebo treatment. I.e., the 300 and 450 mg doses were highly stat sig on the primary endpoint.

"Statistically significant efficacy was also seen in both the 300 and 450 mg treatment groups for the two key secondary efficacy endpoints including one assessing response (responder/non-responder) to study drug during Weeks 1 to 4 where “responder” is defined as having 3 or more RFBMs per week, with an increase of at least one RFBM per week over baseline, for at least 3 out of the first 4 weeks.". Were there any secondary endpoints where stat sig wasn't met?

I don't know much about Relistor or PGNX, but I'm reasonably adept at reading a PR in a skeptical fashion.

Believe me, I appreciate the skepticism and we won't know for sure on the secondary endpoint questions until we see the full data set. I am not certain of all the secondary endpoints, but I think it's interesting that they note "the two key" as opposed to just "two key" secondary efficacy endpoints. The way I read this, if there were other secondary endpoints beyond these two, the companies at least consider them of lesser importance than the two where stat sig was met. Let's wait until we get the full data set before we assume anything for sure but I am not inclined to sell my PGNX position after this news.