Herks, are you plunging your hands in your pants and squeezing your nuts, and wondering if your boss will keep you on at three thirty five an hour now that you have let the price go up by 17% in the last 16 trading hours?
Armed, I can't explain why Herky loves me so much but he extols me every chance he gets.
Herky, send me you address so I can stick you on my Xmas card list. Seriously Herky, make a play. Do you think the company won't be able to send the price up to 3, 4 or 5 dollars with one or more of the seven randomized trial they have cooking. Don't expect this by next Wednesday ... we will see the good stuff in the March to June time frame and that will only be the beginning.
Sentiment: Strong Buy
All sorts of fishy things going on. Three insiders wait to buy shares on the open market AFTER the lesser part of the PIII data is released. Why didn't they buy at $2.5 before the data came out? Oh wait, they could have seen that the combined regional data (unblinded) had an OS of 130 days and figured out this might not be definitive. They would also know that the company was splitting the population along true distal and local. The population they are assessing has changed each time they have given an update and they never say why until the analysts drag it out of them. I am surprised the company is playing this game. I would have thought they would have had a buy/sell black out period that completely surrounds all of the PIII data releases. This really creates the appearance of insiders knowing what is going on ahead of time.
Well, we can probably take this as a good sign. The insiders probably have some inkling of what data is coming and more importantly when. They could have waited for the price to drift lower but they locked in their shares shortly after the PIII data. They may have purchased in December in advance of entering another black out shortly after the new year. I have to wonder if BT even knows what a blackout period is.
Rat, You appear to have missed the point of my post. They now understand that local solid tumors in head and neck is probably the least favorable indication for REO, but it still had an OS improvement of 30% and a PFS improvement of 88%. I don't remember seeing numbers this good for anything in the last decade. But my research tell me this will get better. I will not be surprised if the H&N mets, or panc, or SCLC had a doubling of OS.
Anyway, you seem exceptionally angry at this whole affair. It might be better to stop obsessing about something you don't own and move on. Your life is passing you by.
"Find something else to obsess about and better luck next time. Your life is passing you by."
This is not life. Back packing with my family and friends, sailing, maintaining my fruit orchard, playing the French horn. That is life. As to this, this is a small but useful hobby. I have been in drug development for a couple decades. Its hard to get motivated do the same thing you could do yesterday or five years before. Investing energizes me. Doing research when you have skin in the game is so much easier. You don't put it off, you just do it.
Now, since you are one of the more intelligent Debbie Downers here, I am having a hard time figuring out why you think they would be able to unblind when they think the median has been crossed. One, they don't know that and, two that are gunning 10% to avoid error biasing. Can you please explain your thinking here?
Final thoughts. The have cordoned off the worst data population on the worst indication and it still did quite well. The future data looks promising. I think you will have a hard time scaring people off of this in the future.
Merry Christmas Ratticus
"And counting each new day as evidence of greater efficacy may not be valid"
If you believe the historical data (which has been amazingly accurate on this trial as predicted by the PIs) there are no patients left on the control in either the local or the mets at this point. At 420 days there may have been one patient on the control (based on the zenda paper) but the had to get down to 11 to unblind. The time was defined almost exclusively by the events on the control. Now we are out beyond were any control patient has made it. The absolutely means that the unblinding will occur when the fifth test patient move on...... the longer the better.
I think you might be trying to make the point that each day/week/month we need to wait won't translate into the same number of days of OS improvement. That should go without saying. I had a detailed post describing the relationship between the number of patients still around now and the OS. The bottom line is the more we need to wait, the further out in time the OS will have been reached.
What? What? and What? Right now there are 49 patients that have distal mets. Nobody, including the CRO and the DMC knows which of these is treatment and which is control.
What point are you trying to make about the local regional? The waterfall chart is fairly unimportant at this point since OS data is now unblinded for this group.
The short interest just dropped another million shares ... even after the ambiguous news from the last NR. It almost seems like the entity buying knows the shorts need to get out forthwith and is offering them the opportunity to get out now at 1.64. Take our offer or fence your shares at a premium. Just a guess. But, this was one of the most bizarre trading days I have seen in 6 years. Which one of you lads (lasses) took out 86.4 K shares?
I have been looking for SCCLC outcomes in anticipation of any survival data we might get. If you google "kaplan meier curve for stage iv squamous cell lung" the top hit is a review article of stage IV NSCLC with the histological sub types. SCCLC is usually not broken out as a separate population in trials, but this retrospective analysis shows that the OS is only 4 months. It might be a bit longer now (this only analyzed data to 2003) but even when gem is stack with cis it only adds about a month of survival benefit. SCCLC probably has an OS with current therapies of about 5-6 months. This trial finished enrollment 6 months ago and by now they will have a very good idea how well it worked. We will probably see this no later than ASCO, but hopefully sooner. I have been waiting to buy another large block of shares but I want to see more risk removed. If the OS for this trial points to 13-14 months like the NSCLC data, this might be a good buying point. The market won't recognize the value of a single arm study and the price won't go up too much.
Sentiment: Strong Buy
Fox, another place where we might be seeing more of the immune effect is in the NSCLC trial. When you look at the poster on the website, the median number of treatment cycles is about 5 or about 100 days (reo may had added an extra 50 days of treatment compared to standard chemo). I had kind of written off this indication since the responses were so so, and they would probably have to reduce it to a genotypic sub population to get it to work. I was somewhat shocked to see that 59 % of the patients went out beyond a year. Stage IV have an OS of 8 months. The group they were treating might be even less since the were half IVb. The bottom line is this survival benefit goes beyond the incremental length of time that REO adds extra disease control.
Reo may have no more or no less immune response than the U Penn therapy. If reo was used to treat a hemapoetic malignancy it might have a much more durable and lasting response because there isn't a need to penetrate a tumor. We might get a clue about this when we see the myeloma data.
If the Upenn therapy just causes an immune response by letting the body "see" the antigens after the tumor cells are popped, it might behave just like REO. I need to look up its MOA and see if they even claim they are introducing and antigen with this therapy.
For the late stage solid tumor studies reo has been run in, as BT says, the immune response come 6-9 months out. For the current had and neck data we can see, many of the patients are around long enough for this effect to fully manifest itself. I think the metastatic patients might have more of the immune response going on since they on average will make it long. If you look at the PII data, the tail is quite big and it extends out years beyond the last possible treatment the patient could have received. This definitely smacks of a learned effect by the immune system. Hopefully the second population Harrington refers to (with the longer OS) is the mets group.
The company has made it clear that they will wait until the data from the randomized trials that are underway come into view before they think about partnering/ buyout. No one buyer will get to see material data (even under CDA) before another one does. As early as a year from now we could see hints or leaks of bids. Two trials showing stat sig on OS could drive buyout floor to 50.
So you don't know how a bunch random ticker symbols that you don't own are doing. Let me repeat myself: get help.
Some of those are down, and those that aren't are not development stage. Seriously, it might be time to see a doctor.
"Jennerex JX-594 fails PIIb liver trial, that's why"
No. Kerx: -11.5 %, LXRX: -10.3 %, CLDX: -5.1 %. Development biotech got hammered today. ONCY did relatively well for a day like today.
What difference does it make what the price is now? Look at some of the concerns that have broken out of the sub $10 range. Once the data comes into view, bang, you have many more willing buyers and the price get well into the double digits quickly. The key ingredient is data. We only have a crumb of randomized data that hasn't removed much risk. It clearly says REO does something but it needs to be rerun properly to get it to "work" (show stat sig). Mets, panc, and ovarian can break it loose. We only need to see one data set with a OS p less than 0.05 to get this going. After a decade there are 7 of these in the works or nearing completion. This year could get a little crazy.
You need to work backward from what we know about when people got on trial. BT said they got about 50 in the last two months leading up to the end. That leaves 37 enrolled between March 31 and about July 15, 2012. The next 40 got on between ca Dec 25th 2011 and March 30 2012. The fist 40 got on study before Dec 25 2011. 49 of the 167 had mets or 29.3 percent. If you multiply the number of patients in each time bin by 29 percent you get, 14.5, 10.73, 11.6 and 11.6 mets patients getting on study in various time bins. Next assumption: there are 7 patients around (there might be more but I say this because BT said a few more events have to occur) We need to get to four (to be less than 10%) so a few events could be three. Now, another assumption is none of the remaining patients from the control group are around. The last patient from historical studies moves on at slightly over 400 days. That means that only half of the patients in the time bins are available to contribute to the survivors. i.e. 14.5 becomes 7.25 test mets that were enrolled in the last two months etc.
To model this you can create a column in a spread sheet with 0 to 24 months. Next, you make 4 columns with exponential decay curves with their multipliers set to 7.25, 5.36. 5.8. If you set the time constant for each of these functions to 0.07 you get exponential decay curves with a half life (median OS) of 10 months. You will see that at 15, 17, 19, and 23 months (the time when the last patient got on study in each bin) you get contributions from each bin of 2.53, 1.63, 1.53, and 1.15 for a total of a little under seven.
I added half a month to the 10 month OS because all of the patients didn't get on the last day but they are spread out over 2 to 3 months. This is conservative.
These numbers are small and make an accurate prediction hard, but they do point to the most probable scenarios that is occurring.
One more theme I picked up on was their focus on the secondary immune response and the need to move this to the first line to take advantage of this. BT mentioned of the local group that the response eventually stops working (he phrased this several ways). It seems he is implying (somewhat like Harrington said about fist line) that if you can get past the original chemo regiment and the patients have enough life/organ reservoir, the immune effect can take them much further into the future.
BT seemed calm and in control with clear straightforward answers. When asked specifically about how well they know REO is working in the lung indications he said the disease control and the PFS is double what one would expect from historical data. I think he was being conservative. The one year survival on the NSCLC is 3.6 times the best that has been reported in the past. The bottom line is they are not panicking. They have put the less than interpretable number for local H&N behind them. They have randomized trials finishing enrollment and they will be able to pick and choose how to finance based on the news stream. We used to say 2010, and then 2011, and then 2012 will be the pivotal year. With the release of three to five randomized data sets this year, we will finally have a real picture how well REO works in 2014.
The interviewer alluded to the fact that H&N probably shouldn't have been the lead trial based on what they now know about other indications. I think this sentiment is probably shared among other analyst. All of the other indications are much more enriched in mets. Panc 70%, MCRC 100%, Lung 100% (everyone was stage IV in the current trial). One additional thing I got from this, although BT won't claim to know when the third party trials will finish and report because "it is out of their hands" they probably know exactly what is happening on those trials. He seemed very informed about the panc patient that has received 34 cycle (and counting) (over 700 days on study). I would imagine they have an even better view of the NCIC trials. The NCIC trials have been enrolling for 1-1.5 years (and according to the company the NCIC almost always hit their enrollments in 12-15 months) I will be pleased if the NCIC MCRC or lung finished enrollment H1 2014.