I note that in the May 5th cc, Dr G was very enthusiastic, and even joked about "modesty getting you nowhere." There's an implication in the Nov. 5th cc that we don't have mature data for OS in TNBC because patients are staying alive for so long. And yet, we know very little about how long the 60 patients at issue are actually staying alive. When he made that statement, there were patients who had just been enrolled a few weeks before. Speaking on behalf of "Joe Public", it seems to me that 40% maturity indicates that 24 of those patients died as of May 2016. (I think I recall that none had died as of Dec 2015.) So, the interim median OS tells us that 12 patients so far survived at or beyond 14.3 months. Please correct me if I'm looking at this the wrong way. I know sometimes they look at a whole population wherein the data is still not mature, and then use censoring to prognosticate such things as OS for that entire population. Intuitively, I think such a statistical trick has little utility in such a small population, and the principal investigator seems to back up that sentiment in his statement that I previously referenced.
If the above analysis was carried out correctly, we can then deduce that 36 patients were still alive as of the May 2016 reporting. We also can say that at least some only enrolled 7.5 months ago. I just want us all to be aware what IMMU is betting the company on when we talk about TNBC patients "living so long." In fact, there were a total of 20 patients that had an objective response in the cohort at issue.
When you look at SCLC, we're looking at 3 of 33 patients who had a confirmed response. It would be pointless to attempt to attribute anything to such small numbers.
To demonstrate the impact that even two patients can have on median OS, let's consider 9 patients with the following OS in months: 1,2,4,5, 10, 12,14,15,15. If two more patients who have entered the trial die at month 5 or before, the OS moves from 10 to 5 months. I just want us to understand what we are betting the entire company on.
The data shows early promise, the key word being "early." We need a partner to see it through and de-risk the current state of affairs in which we find ourselves. I wonder why, when Dr. G knew the results and even already presented those results before ASCO, why he was so enthusiastic about the updated data that would be presented (not) at ASCO. We can say that if that enthusiasm translated into even an extra couple dollars per share, his recent planned sale of shares would have grossed him another million dollars. When he does a cc that may have a direct effect on the share price, knowing that he will have trades executed in the near-term, he is working with real data when what he offers the rest of us schmucks is partially obscured data propped up in its best light. I don't see how that aligns him with the common shareholder. And again, with being able to refill the coffers at will with new shares, he has nothing to lose in continuing to implement this strategy of robbing us blind.
If he knows exactly when each of the surviving patients enrolled in this uncontrolled study, why do we not know this? Certainly it is relevant, but I'm not the guy to ask as to whether it is material from a legal standpoint. |
