Late yesterday and this AM I spoke to a couple of micro-biologist MD's (researchers) who work at MD Anderson. Told them the story and described as best I could the DNA test that's taking place...So I'm not sure I got my part right. BUT what they said, was that it didn't sound like this was a "clinical trial", but more like a correlation test (and they compared it to classic allergy scratch tests to make it simple for me). They said that they're probably looking for a pre-screening test to indicate at risk patients based on their DNA to determine the profile of exemption candidates. I asked two questions:
1. How long should these tests take to complete? They said, depends on the size of the population being studied AND whether they're looking strictly for exemptions AND/OR remedial actions in the respondent populations. So I pushed them a bit to get their best guess as to how long they thought it ought to take...Answer...2-3 months.
2. How long does it take to actually get the results back once a patient has the test...Thought I was going to get a simple answer to this one. They said these kind of tests typically have a 3-5 day turnaround, BUT that it also depends on how many patients are in the study group AND whether they're using an on-site laboratory or third party. One of them said it also depends on whether they're DNA testing ONLY the reactive patients or all patients??? I got the overall sense that the overall estimate for test turnaround was about a week or two.
I didn't want to wear out my welcome on this. I know one of these guys pretty well and he referred me to a doc I don't know at all who he said would probably know this area better.
Conclusion...Sounds to me (to extent I got this right) that EOY should be the latest and more like somewhere between October and EOY.
DNA test sounds a bit sketchy. Based on what's public knowledge, I am surprised they aren't going with just a test of hypersensitivity, as a DNA test would never tell you how the patient will react. Any thoughts on what exactly they are going to be testing for?
Mersh...good question...What I was able to get from the two microbiologist is (and they were answering based on what I told them was going on...so this could be subject to misinterpretation on either side)...A DNA test is effectively a set of correlation tests used to try to connect genetic "connections" to various outcomes. As such it is why I believe (though they didn't say this) that the tests will occur upon reactions rather than the entire test subject population. Once they get a "hit" they would do the genetic sampling and testing immediately. This will continue long enough for them to correlate any statistically significant leak to a particular gene. IF there's a high correlation then it can be used for pre-screening IF the incidence and severity rate warrants.
I'm certainly not an MD (I am a MaxDad), but I'm guessing that it is not likely to produce anything but only time will tell and as I indicated in prior post, the Research Microbiologists (both MD's) I spoke with thought it was likely that this would take a few months (2-3) and so I concluded that this should all be over in Q4 and no later than the end of this year. Again, we just need to see it through, but this should be the LAST HOOP before returning Omontys and we could certainly see material actions between now and then depending on what the rest of the investigation determined (which most of us believe is that the 3 deaths were HUMAN ERROR).
Many thanks, MaxD. I see they are pushing it down today for no reason - may be weak hands are grabbing a temporary profit. Let them push it down a bit more, I will load a ton. Another triumph at QCOR front - looks like it is heading toward three digits. Congrats!!
It depends on the purpose of the test.
Are they trying to develop a pre-test that will be administered to all potential O patients at the infusion center in order to screen out potential hyper reactors? This would be a major undertaking, especially with hyper reactors being so rare. Any such test would require FDA approval prior to marketing, which means large-scale field tests with enough subjects to establish statistically significant estimates of sensitivity and specificity of the test. Given that nobody even knows if there are any DNA markers for this hypersensitivity, this would be a long-term and risky undertaking.
On the other hand, the purpose may be to show good faith to the FDA by helping the scientific community understand drug hypersensitivity reactions in general. If so, the research on such a test could be done AFTER re-launch of O. In the meantime, infusion centers (Fresenius et al.) would need to be much more diligent about watching patients for emergent hypersensitivity reactions and treating them promptly. Which, by the way, they should have been doing all along.
Stoutsval, I believe you are right on the mark. I have a range of (0.0067 to 0.00368) subject to a sensitive reaction. A better understanding of genotypical traits, foreign material, and anti-bodies would help.
stoutsval: So now that it seems confirmed that its an allergic reaction, wouldn't a strict protocol for monitoring the patient for such reactions, accompanied with an equally immediate protocol to remedy such allergic reaction, should it occur, be sufficient for the FDA to allow the re-introduction of "O". I think yes based on the low probability of a fatal reaction, and a high probability of immediate remedy, and a higher probability of healing the patients disease. Imo I think its ready to be reintroduced. Or have I oversimplified this?
max: wish I had more cash as the Oct. options will be cutting it close if this scenario plays out and stalls the pps climb. However, would this stop any re-introduction before such test completion, or say buyout?