NorthWest Biotherapeutics Inc (NWBO)

[JRIII]

Thank you for posting this balanced article. It's a shame that many here will fail to heed its very clear warning.

Afterward, the trial continued for another year and a half until August 12, 2013, when, to everyone's surprise, Vical announced Allovectin had failed its clinical investigation and did not meet its primary or secondary endpoints. In other words, Vical had severely underestimated SOC's efficacy in fighting off melanoma and prolonging patients' survival.

There will be a very similar outcome here. I have been saying this for more than two years now, so no one should be surprised when NWBO announces the failure of DCVax-L to meet the endpoint targets. The company has known about this failure for six years now but has not said anything to shareholders. Nor have they shared exactly what their revised gameplan is since learning about the likely Phase 3 failure on the defined endpoints. All we know is that it has something to do with a "long tail" and that maybe they are trying to convince the FDA and other regulators to make an exception for their failed trial based on some after-the-fact indicator regarding a small subgroup, or they are looking at combo applications (even though that's not what the Phase 3 trial was about), but the bottom line is that they've never actually said anything to shareholders or shared details of the new strategy. The original endpoints remain unchanged on clinicaltrials.gov, so nobody knows what the plan is. All we know is that when they learned the trial likely failed sometime in 2014-2015, instead of announcing that information publicly and starting over with a new, better-designed trial, they instead decided to cover up what they knew and continue raising money to pay themselves $500,000 salaries, along with conducting numerous insider transactions that resulted in their personally pocketing millions of dollars in additional profit, all of which occurred as the share price steadily lost 95 percent of its value.

This is from the subsequent class-action suit filed against Vical:

According to the complaint, the company made false and misleading statements and/or failed to disclose material adverse facts about the company's business prospects and financial condition. Specifically, the complaint alleges that, throughout the Class Period, Vical misled investors about the efficacy of Allovectin and the likelihood of its success in the Phase 3 trial. Further, the complaint alleges that the company deliberately delayed the announcement of the results of the Allovectin trial to avoid revealing the truth to the market.

The case against NWBIO will be much stronger. In fact, I would not be surprised to see a criminal component.