You have about 350,000 posts to read going back about 10 years to fully grasp the nature of this company and its future stock potential. Once you finish reading all of those posts you will come to understand that we are right back where we started. Nothing has changed except that the stock showed a brief upward spurt to $2.50 last year based on the company CEO's false promise back in April 2020 that they would lock data on this 14-year-old trial and release top line data in short order. They subsequently pushed that timeline back multiple times, and even put out a statement promising TLD in September 2020. Then, in October 2020, they put out a press release stating they had just locked the data (?). Yes, I know, it's all very confusing.
Since the company blew all the good will and excitement it had generated with the data lock and TLD announcements, the stock has since settled back to the $1.50 range. Most of us recognize this is an unrealistic price range for much longer unless the company finally gets off its ass and does something. They have not communicated with shareholders since that October press release, and the fact that we are now into February 2021 without TLD is not an encouraging sign to say the least.
Some people think they are waiting to publish trial results in a top-tier medical journal. Others of us wonder why, if the data is really as good as some think it is, they would wait to publish a peer-reviewed article when all they really need to do is put out a simple press release announcing whether or not the trial hit its (new) endpoints, and then worry about a journal publication later. Yes, I know, it's all still very confusing.
About those changed endpoints: after 14 years of conducting the trial and right before they decided to lock down the data, some iHub posters here figured out the company has been trying to change the endpoints on the trial. As you can imagine, changing the endpoints on a 14-year-old trial right at the last minute is a highly unusual move and one that wouldn't typically portend good news about the data. But some of the folks here found that the endpoints on the European regulator's web site had been changed (but not on the U.S. FDA clinicaltrials.gov web site). Yes, I know, it just keeps getting more confusing.
Have the changes been approved in Europe but not in the U.S.? Why hasn't clinicaltrials.gov been updated with the new endpoints? These are simple questions that most shareholders would like to have answered, but the fact remains that the company has never said anything to shareholders about changing the endpoints at all. For all we know, it's just another in a long, long list of distractions they have thrown out over the years.
Some of us believe that the company actually found out sometime in 2014-2015 that the trial likely failed to show efficacy on the (then) primary endpoint of PFS. Some people here (or one person anyway) will tell you that a lawsuit filed against the company during this time frame that was subsequently dismissed by a judge proves the company did not learn the trial was missing on PFS efficacy. But others of us believe that the lawsuit was filed just after the company had conducted an Interim Assessment on trial safety, but just before the company conducted an Interim Assessment on endpoint efficacy, so discovery in the case did not include the latter IA's bad news. The greater point is that if you don't think the company had an idea of endpoint efficacy after eight or nine years into the trial, you would have to be either crazy or disingenuous. All of this was concurrent with the FDA halting any new enrollment in the trial for reasons that remain unknown to this day, although the FDA lifted that restriction about 18 months later. And it all coincided with the company crawling into a cave and clearly making the conscious decision that the less communication with shareholders the better, and that the less people know about what is actually going on with the company and its Phase 3 trial the better. It's also around the same time that they completely changed the focus of the trial to concentrate on the alleged "long tail" of survivors, the supposed "gold standard" of GBM drug studies, and hitting "home runs" with that "long tail" data. Why they did not start out using the "long tail" "gold standard" as their primary endpoint, no one has been able to explain.
So here we are, more than three months since they allegedly locked the data and we have not heard an official peep from the company. The people in charge are still the same people who have made millions and millions of dollars by keeping this sham going all these years, and ultimately they have produced absolutely nothing. Now, they are refusing to release the data. So congratulations on your stock purchase because, as you can see, nothing with this company has really changed at all. Your timing is perfect because you haven't missed a thing. It's all still very confusing.
