According to my spreadsheet, mortality predictions are as follows:
Total number of deaths (as of 4/30) if OS was 14.6 months and ICT-107 provided no benefit - 58.3360
Total number of deaths (as of 4/30) if OS was 18.8 months and ICT-107 provided no benefit - 46.1218
Total number of predicted ICT-107 patient deaths by 4/30
if ICT-107 functioned identically to Phase I - 3.3158 out of 83
Total number of predicted control deaths if OS was 14.6 months (as of 4/30) - 19.4453 out of 41
Total number of predicted control deaths if OS was 18.8 months (as of 4/30) - 15.3739 out of 41
Total number of deaths (as of 4/30) if OS of control was 14.6 months and ICT-107
functioned identically to Phase I - 22.7612
Total number of deaths (as of 4/30) if OS of control was 18.8 months and ICT-107
functioned identically to Phase I - 18.6898
(Total number of predicted control deaths if OS was 18.8 months (as of 4/30) - 15.3739 out of 41)
Folks, this is why IMUC is still very very very very risky. Although it seems ICT works the question of how well is still totally unkown! First 18.8 months is probably 10% low on the survival time for completely resected patients. Take into account the complete lag time from the 32nd death to the actual public report time being like 3 weeks and it becomes highly questionable wheter we have a significant survival benefit at this point! Remember even if ICT works if a P3 is in the works you wont see anything above $3 for years but could very well see sub $2 on further dilution. IMUC is not selling for $2.40 for no reason..........Remember: Father knows best. This is why Ive sold half of my investment here and moved it to NWBO. Two big unknowns, LasVegas style.
$7/share is a fair price now. We are talking about a treatment for cancer now that will be in high demand. The stock should be trading in the mid-twenties upon approval. I can honestly say that I have never offered anyone a bad deal in my life with the hopes of taking advantage of them. I only offer things that I think are mutually beneficial for both people. I think this price is a rip-off for sellers. If you are happy with your position now, then good. You don't need to buy anymore. But I completely disagree that it is anything but moronic to buy a price that is basically this price, take all the risk in the world, and then when efficacy is demonstrated, to basically accept selling at the same price. If someone wanted to buy at $2/share, then they should have had to have bought this stock before it was demonstrated to have been effective in a Phase IIb trial. Someone else might be dumb enough to sell their shares at this price right at the moment, on the hopes that the person who bought it from them is dumb enough to sell it back to them at an even lower price, but I am not subscribing to that line of thinking. The people buying now know that this is an effective treatment and eventually we will run out of suckers.
We don't have 100% fully resected patients in this trial. I like the decision to diversify. I like NWBO technology and feel that it compliments IMUC's technology well, but I don't like the management in that company or the fact that the trial has gone on forever and they still haven't reported how many people they have in their trial.
I completely disagree with your assessment that a Phase III will be needed. You need 300 patients in a typical Phase III trial, if your label is to treat all of the GBM patients. HLA-A1 and HLA-A2 patients are about 60% of the population and patients that have not had recurrance are a percentage of that. We had to enroll 278 patients to treat 124. The company did it this way for a reason. They want to demonstrate that 124 patients enough for approval because they had to enroll 278 patients, simply to treat that many patients. The entire purpose of the trial is to treat a portion of the patient population before the treatment is shown to safe and effective. The FDA will require a company to treat 300 patients in a trial so they can treat 10,000 a year, but they won't require a company to treat 300 patients in a trial so they can treat 4,500 in a year. Using OS here as the primary endpoint is the perfect strategy here for seeking approval. You can't argue with alive or dead.
Also, while having a diversified portfolio is a always a great idea, I disagree with your perceived risk of IMUC. This company was far more risky in November of last year than it is now. Anyone could say that while you might have had a 38 month OS with 75% fully resected patients and only treating 16 of them, you could have had a 20 month OS with a much lower percentage of resected patients with a higher number of treated patients. You can no longer say that now and we are talking about a cure for cancer. $2/share may have been a fair price in November. $7/share is a fair price now.
you will definitely see upside if there is success probably to 300 ish million cap
also you either believe it works or not dont invest based on these charts and there is some expectation of accelerated approval even by the lead investigator of the first p1 trial
"One cannot predict what the FDA will do, but we don't have a lot of patients with glioblastoma, as we do with breast or lung cancer, to get a lot of major pharmaceutical companies excited. I think the FDA has an interest in trying to move products like this along a faster track so that they can get this to patients who desperately need the therapy, but a lot depends on how robust the signal is in the phase 2 trial," Dr. Black explained.
neurosurgeon Keith Black indicates pretty clearly that there is a hope for early approval
also there was huge efficacy in the first trial and there are now booster vaccinations to derisk...so the real question of risk is whether or not they cherry picked the patients or just got lucky with antigen frequencies in which case do due diligence on NCBI and find lots of data backing this up
Disco, according to your model - when would the 32 deaths occur with OS of control was 14.6 months and ICT-107 functioned identical to Phase I?
When would the 32 deaths occur with OS of control was 18.8 months and ICT-107 functioned identical to Phase I?
It certainly appears as if Q3 is a possibility, if ICT-107 actually has a 38 month median OS. I ran the numbers out for 30 months. I need to interpolate more data if I am going to calculate all the way to the end of the trial. I might want some assistance in getting some mortality numbers to go all the way to 64 deaths. I'll be on Yahoo messenger if you want to have my file attachment or would like to assist in any way.