Yes, those are a direct quote from Harvey Berger in an earnings Q release.
Any way you cut it: he was giving the impression to shareholders there was a strong probability of this happening (heck, theres a probability that the drug wouldnt work at all----why didn't he say that???). He didn't say it WOULD happen...but it was inferred...OR HE WOULD HAVE NEVER SAID IT IN THE FIRST PLACE.
Either way, I believe many investors were taking the bet (on his words) that the 2nd interim would lead to an NDA. Those investors gambled, and lost. I believe, along with the overall market, this is why ARIA has been deflated 25% or more since the announcement that the trial would proceed to the end.
From my point of view, if I go by Dr. Berger's words, to me, it says his calculations on the efficacy of Ridaforolimus in the SUCCEED trial are "off", and it calls into question the overall success of the trial IMO. Clearly, he was counting on the drug being powerful enough to show a statistical significance at the interim - it didn't. Why? It's possible the drug isn't showing strong efficacy, or it's possible the placebo group is progressing longer. Or, the DMC just didn't want to end the trial because the arms are too close right now at the interim.
Either way you cut it, the trial is continuing because the drug didn't meet the criteria to stop the trial - which, is a negative IMO - --but isn't a disaster...the trial still continues.
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