What does this mean?
However, the study did not meet its second endpoint evaluating a separate score, with a distinct set of genes, designed to predict which patients experience greater relative benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery.
Ok. Fair enough, but my point about 5FU was that this drug, even though it was licensed for use in the 1950s, is still the mainstay drug of treatment in colorectal cancer and will be for many years (or its oral equivalent). It's a major disappointment that the results supposidly don't give a predictive result for chemo benefit because that is the main reason that Oncologists and breast surgeons use the breast Oncotype Dx rather than the fact that it gives a more accurate risk assessment.
RE: "You have to be objective."
I am objective....I pointed out right away the colon results were good and bad.
RE: "As for being anonymous, you're not exactly posting your name, picture and your cell phone number on here and neither does anyone else so I'm not sure what your point is."
The point is, GHI is happy with these results....the analysts are happy with these results, but you are telling us something different than they are. I am not telling anyone to believe me over them.....you are.
RE: "It doesn't become you to jump all over people just because they say something that disagrees with you."
Let's get this straight, greggie....you misquoted me....I corrected the misquote. You disagree with GHI. No disrespect to you, but I think I'll follow their opinions over yours.
RE: "The stock's not going to move up because you talk it up on this message board."
I have never once "talked up" this stock here and on the contrary I have repeatedly said don't sweat the day to day moves in the stock price....watch the SCIENCE...the science is great and eventually the stock price will follow.
I am an investor in this company and still hold the stock. I review the data with a critical eye. I agree this wasn't a home run. You have to be objective. When the results of the trial were announced around April 14th the stock was trading at $25 to $26 and it is now trading at less than $19. As for being anonymous, you're not exactly posting your name, picture and your cell phone number on here and neither does anyone else so I'm not sure what your point is . Take my comments with a grain of salt if you like but my posts are always informed and I have a right to post my opinion. You won't get rich in this game unless you are analytical and objective, especially in these type of biotech companies. Lots of these companies have promising technologies which are superceded as the years go on. It doesn't become you to jump all over people just because they say something that disagrees with you. The stock's not going to move up because you talk it up on this message board. The medium term catalyst in this stock is increasing and international sales of Breast Oncotype Dx.
RE: "the previous poster who said that 5Fu being an old drug and not relevant was wrong.'
careful there, cowboy.
What I said was:
"5 FU is a VERY old drug." This is true....40+ years in use....without question one of the oldest chemotherapy drugs.
"many other newer drugs in this space now." Also true.
Did not say 5FU was "not relevant."
As I said, this was not the best outcome for GHI's colon assay but it was not the worst either...by far. It's a second product in what was a one trick pony company. The science works....it will evolve and grow.
GHI is okay with it.....the analysts are okay with it.... anonymous internet message board poster "greggiew" has issues with it.....taken with a grain of salt....
I agree with all of this and it's a good summary of the perceived downside to adjuvant. The thing is that in colorectal cancer, the combination of grade, T stage and nodal status in the vast majority of cases will tell you whether or not a patient needs adjuvant chemo - ie Dukes stage C should have adjuvant chemo by most standards given the risk tends to fall over a certain threshold - can you really see many cases where the Oncotype colon test will tell you that the risk isn't high enough for chemo in a Dukes C? - maybe but not often. Dukes stage B is the grey area and good Bs probably don't benefit much from chemo - ie. pT3 N0 with no bad features. Results from trials suggest a 4% benefit with B, but that includes good Bs and bad Bs and subset analysis of the trials has not given us the answer to which ones benefit and which don't. If there is only a 4 % benefit that means you have to treat 100 patients for 4 to be saved. That's 96 patients who get chemo for no benefit out of 100. A lot of patients won't go for that. Many patients are elderly. I admit some will but a lot won't. Subset analysis of the Mosaic trial suggested that benefit to Oxaliplatin over 5FU was nil in Dukes B so the previous poster who said that 5Fu being an old drug and not relevant was wrong. Dukes B patients often are offered Capecitabine or nothing rather than Oxali which tends to be reserved for Dukes Cs on this basis. The patients you want the Colon Oncotype to give you the answer to is the Bs. The trial supposidly hasn't been able to predict who will benefit so it's possible that it will only be used by oncologists/surgeons to differentiate between good and bad Bs, and we often know that anyway from pathology results - presents with bowel obstruction, perforation, neurovascular infiltration etc bad. Otherwise what is the point of getting the insurance company to pay $3000 for it if it doesn't help your decision making? That's the point. It doesn't help the decision so in most cases it would be an academic $3000 spent rather than a useful one. JMHO
Adjuvant Online! is a wonderful computer model that will generate the kinds of cool probability estimates you describe. HOWEVER, even the creator, Dr. Peter Ravdin, is a big fan of Oncotype DX. According to him, you can use his model to estimate certain probabilites as a baseline understanding of your chances for future events. But the computer model has 2 permanent limitations: (1) The results of running the model for any particular case will never be any more accurate than the least accurate input you enter into the calculator. So for example, if the tumor size estimate is 1.1mm instead of 0.9mm, this can change everything. If the ER status is not accurate (error rates for IHC testing for ER vary between 5-10%), then the model is worse than useless -- it will be totally misleading. The only input value that Dr. Ravdin has confidence is generally accurate is patient age, everything else is subject to some degree of error, and most cases have at least one such error that could become an erroneaous input. (2) The computer model does not look at your actual tumor biology. No computer model can ever capture the richness of the information contained in your actual tuomr cells >> Oncotype DX is designed specifically to meet this need.
Adjuvant Online answers this question:
Assuming all the inputs are accurate, if there were 100 patients with the same exact disease & demographic parameters, what would the distribution of outcomes look like and what would happen to the average patient in this group?
This is valuable to know, and this explains why this tool is so popular with treating physicians. The best oncologists use Adjuvant Online early in the treatment planning process to understand the range of possible risks for an individual based on the gross phenotypic findings and the qualitative report from the anatomic pathology department. Then they run Oncotype DX to interogate the tumor biology in a way nothing else can match. These tools work synergistically, which is why Dr. Ravdin has built a version of the online calculator that explicitly incoprporates the Oncotype DX Recurrence Score. He is actively collaborating with GHDX, or so he said at a recent conference.
Everything I said here is based on the existing breast cancer assay, but the same would hold true for colon cancer. I anticipate a strongly positive reaction to the colon assay when it hits the market.
RE: "This means insurance companies won't cover it"
Well looky looky who's back....it's old chippy....probably figures the passing months have made us forget some of his previous poor projections. Here's a little trip down memory of just what chip brings to the table:
GHI's profits and market share will fall due to Mammaprint?
FDA will regulate Oncotype Dx?
Fishy insider sales forecast doom?
GHI will have to lower price of Oncotype due to Mammaprint?
Oncotype will be irrelevent?
Now this joker wants us believe insurance won't cover the colon test. Based purely on his track record, I will say it gets covered without a glitch.
But let's be a little more scientific. Currently, stage II colon patients and their doctors are throwing darts. Oncotype provides real science....personalized medicine...the future. Insurance companies know that. Getting the breast test for node neg covered was tough....getting node pos was easier....getting colon covered will be easier still, imo. The insurance companies KNOW the test...they know what it does...they are on board the personalized medicine train.
We all know GHDX has a large short position. Based on chip's track record, one can only assume he's part of that group......which is fine....if he shorted a few weeks ago, he made a nice profit.....but investors would be well advised to consider his angle when reading his nonsense, though.....
Follow the science......the science is great...the stock price will....eventually...reflect the science....
RE: "Judging by the markets reaction it means we're fucked...at least for now.'
I wouldn't go that far. Stock had a strong run recently...no doubt....gave some back since the release.
Meeting both endpoints would have been great.....could also have met neither of the endpoints.
Fact of the matter is...the science works as a prognastic indicator in colon cancer. Did not work with 5FU though. Don't know if it's over with 5 FU, but 5 FU is a VERY old drug.....many other newer drugs in this space now.
And keep in mind, when Oncotype for breast cancer first was approved, it was only as a prognastic indicator too.....the predictive acceptance came later.
Bottom line: not the best outcome and not the worst outcome...but it still brings another product to market and further validates this science in more than just breast cancer. For a biotech-type company to grow, you need current and future products....GHI just moved one from potential future product to marketable in 2010. There will be others.....and international sales haven't even scratched the surface.
Traders in GHDX may be disappointed short term......long term investors should be thrilled.