It is clearly time that they temper expectations. A halt at the first interim is such a difficult thing for any biotech to reach. The fact is that if NW didn't reach it at first IA many here would perceive it as a bad thing. However that doesn't mean the trial won't end in a success. I honestly believe it will.
I also believe that the company tempering any halt expectation will stop the AF's of the world from distorting a successful trial with smoke-induced speculator headlines: "no halt for success, no chance at significance".
Next, it gives the company time to complete enrollment. Since we don't know where enrollment stands officially, we also don't know if Germany has enough patients enrolled to even accept the news of a halt and go along with it. Remember this is a multi-country trial, not just one in the U.S., so having to get all regulators to agree with the decision would take months anyway. No sense in risking an error in the interim.
Lastly, I truly believe the trial will be a success. However, because we were never told how of the cohort split on earlier Ph I/II patients, there's no way of knowing if 1.5 years will be the norm or what the PFS/OS will be for this blinded group. Though, all data that compared Antigen loaded verses DC pulsed lysate revealed the pulsed lysate dc improve PFS/OS results.
As for my comment on the make-it or break-it point, I simply meant the perception of those on edge investors. My dd leads me to believe the technology works.
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