nh, I think that Garnick and the scientists who helped design SUNRISE used a tight margin between the treatment and comparator arms as a tripwire. Apparently, without any major anomalies, the trial design anticipated that after 154 patients were treated, SUNRISE should have produced a stat sig separation of the arms.
The company stated that the Bavituximab arm performed as was expected in the design, and the design was for Bavi to become the Standard of Care. So Bavi reached those expectations...and that's great news for the company, and investors.
But the Doce comparator arm dramatically outperformed previous MOS data for this indication...that was not good news. But you need to know early, and to investigate. That is exactly what Garnick and company were watching out for in the first look-in. PPHM knows that there have been previous strange anomalies in control arms, and even an outright sabotage of the phase2 trial. So, the tight margin was a smart devise.
Another upside to the tripwire heads-up, may have been the opportunity to unblind the trial early with a data group of at least 154 patients, plus however many more were fully treated by the end of February. Previously the company, running the entire trial would have had to wait until December to unblind.
So they have an early opportunity to find out what going on with the Olympic record Doce arm.
You have a packet of 154+ patients, including a Bavi arm that has met design expectations, to submit toward the BLA.
You have an early wind down that saves the company the extra time and money that would have been required had the trial continued on until December for unblinding.
There may certainly be other considerations that Garnick has in mind, but I believe the "tripwire" was the primary reason. Dr. Garnick is a great asset for Peregrine to have directing Regulatory Affairs.
IMO
sunstar
Market Data 
Markets 
AI
