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@ Gold
No one mentioned "respect" in regards to the journals. It is a fact that foreign journals and journals that have low impact factors are considered with less gravity then are US journals and journals with high impact factors.
Yes, I do think that the RECAF test is interesting and has merit as a potential for cancer screening as well. Yes, the false positives are an issue at this point in time without pre-screening. That is inarguable.
On a slightly different note, it does seem that RPC is gearing their product towards a more applicable market with this Mayo trial.
@ Gold
I'm not "hung up" on anything. I mentioned the specificity and sensitivity because I assumed that YOU were using those as qualifiers for "results". Regardless, those accuracy numbers are based on the specificity and sensitivity from the FDA document. Again, how are you so sure that these statistics are the "results" that need to be within 5%? Are there some FDA guidelines? How do you know that they just don't consider one of these? Do you see the ambiguity of that "results" and "5%" statement in that conference call?
It is my opinion that the New test will be better than the current, because they have had years to fine tune it. Just as those results that I posted from the different labs using the CEA test differed, so could the results of the New test. Then again, they could be exactly the same. It is just my opinion that time usually helps refine tests.
Therefor, I can't entirely doubt the validity of their 95% specificity/ sensitivity claim in regards to the New test. I know that you believe that this claim was based on statistical manipulation, it very well could have been. But it is hard to believe that the test reached its potential when it was released years ago.
In regards to that article comparing the different biomarkers. Although, I am weary to trust journals with low impact factors or foreign journals in general, those results are quite interesting but not unexpected. In their CURRENT states, all of those tests do have limitations in their use as general screens. But I maintain that FDP is a very useful substance in the determination of cancerous activity particularly because of its early stage detection capability and can be used to screen given the proper implementation.
@ Runncoach
Yes, I do believe that the Mayo results will show a better test than the one currently being used. As far as sales within the next 12-24 months. I think it's safe to say that the figure is anyone's guess. It really all depends on the PR and I'm not sure how much it would cost to put that PR in place.
However, I am quite confident that if the Mayo results are good then money can be raised. A lot of investors are probably awaiting these results as well and they should be able to fund the production of the kits to meet orders that could potentially be placed.
I listened to the conference call again. I don't think it is conclusive as to whether he was referring to variance in the specificity/sensitivity of the test or the ability of the test (i.e. binding efficiency of the antibody). You are assuming by "results" that he means the accuracy/specificity/ sensitivity. I don't believe that this is necessarily true. Would the FDA require some company to submit a new proposal if they started getting better numbers with a similar antibody? Logically speaking, I don't see a reason why they would.
I need to find out the definition of "results" according to the FDA for this 5% "result" difference. What if "results" only considered sensitivity? What if they only considered specificity? What if considered a different measurable all together? It is inconclusive in my opinion and allows for the possibility of the specificity/ sensitivity to be higher in the NEW test.
If you can find any pertinent information, can you please provide it. Thanks in advance.
By "merchandise" I meant pens, clipboards, etc.
The Mayo test will directly compare the current standard test (CEA) to the Onko-Sure (New Test). Basically, when the FDA results were released years ago, doctors saw the Onko-Sure test as interesting and innovative but did not have real incentive to switch from the CEA test. This head to head test can help eliminate some variables when deciding which test is better on the whole. When they see that Onko-Sure outperforms CEA head to head then they will be more likely to consider it. How likely they are to consider it is dependent on how much PR RPC can get out to the masses about the benefits of their test over CEA.
This should be a bi-pronged attack: 1) The manner which was just recently discussed on this board, the "presentations" all to familiar to those who have been close to doctors and researchers where the drug/ diagnostic companies basically come to your lab/ office and buy you lunch or take you out to dinner etc (they are no longer allowed to give out merchandise by the way). 2) Advertisement directly to the patients or target demographic. Here you can can educate individuals at risk for CRC about their options and give them the results. When they begin requesting the Onko-Sure more frequently, then doctors are more likely to begin considering it or ordering it.
Again, this all depends on how much better Onko-Sure is than CEA as shown by the clinical trial.
"Remember, the FDA is NOT going to let them advertise to doctors that Onko Sure will replace CEA. That fact would garner a fine by the FDA of thousands of dollars. The question now remains. Are doctors just going to use one inaccurate test or two inaccurate tests."
Are you saying that they can't say those exact words/words very similar to those? I'm sure they are allowed to say that Onko-Sure proved to do X and was able to detect Y more progressing cancers compared to CEA in clinical trials. Or that clinical trials proved that Onko-Sure can detect X percent more cancers in stage I or II vs Y percent by CEA in clinical trials. Those are effectively the same thing, correct? Would those be allowed by the FDA?
@ Gold Seeker Interesting. I don't have time to validate your quote of the conference call. I'll take another listen to it in depth when I get a chance. However, my information was based off of YOUR post a few weeks ago. I responded to that post with an analysis almost exactly the same as my previous post. However, you didn't bother to correct it then.
You stated originally that the TEST was changed less than 5%. Now you are saying that the results don't differ by more than 5%. If your original post was a typo, then I am wrong for basing my argument on that typo. Regardless, I'll have to take another listen to that conference call to see if they were talking about the test or the results of that test.
@ Gold I believe you made an error.
"The problem with the clincial trials is the company already knows how the test will perform. They have been working with the test for a year and in a conference call last year, they said it performed within the 5% FDA limit and no new FDA application would be needed."
You meant to say that the physical TEST hasn't changed more than 5%. That 5% change has absolutely nothing to do with the results or ability of the test. The results could be drastically better with only a 5% PHYSICAL change.
"We know from the previous FDA application that the specificity is not really 95% and the test errors 26% of the time when cancer is actually growing."
This is not the SAME test to which they are attributing the 95% sensitivity and specificity. The NEW test is supposed to be 95% sensitive and selective. You CANNOT use that OLD FDA submission (for the OLD test) to judge the NEW test.
Furthermore, that 95% specificity has no data at all behind it YET so it is difficult to make assumptions about whether that is an ACTUAL improvement or statistical manipulation. We'll have to wait for the Mayo data see if this NEW test really has the claimed 95% specificity and sensitivity.
Thanks for the reply. I may be inclined to agree in regards to the test's veterinary potential. I am not familiar with animal biology to the point of FDP level intimacy so I can't make a firm decision.
However, as far as CRC monitoring is concerned, in my opinion, Onko-Sure just needs three things: 1) Good Mayo results, 2) Good marketing, and 3) Supply. Furthermore, I believe, even if the latter two aren't in place, there will be a domino effect for them to be in place. If good Mayo results are announced then it will follow that good marketing will get the word out of the superior product. When orders are placed, supply can easily be produced with the clean sheet resultant of the D/E. Do you see a hiccup at any of these points? Or do you simply believe that CEA is a better product despite its similar numbers and lack of early stage benefit?
@ Gold Do you agree that the most likely reason for this mention and sought approval for a R/S is to have an option that can artificially raise share prices when exercised? This is what I gather from the AMEX de-listing notice which include the "1.00 or above" requirement violation. I am inclined to believe that if the Mayo clinic results are good AND a significant influx of orders is seen, or at least pre-orders, then there won't be a need for the R/S. What are your opinions regarding this specific hypothetical situation? Thanks in advance.
"Robert L. Rooks" is correct.
Is anyone here privy to the MicroStockProfit.com report? I would appreciate it if someone could relay the gist of that report to me. Thanks in advance.
Can you please link me to the document that you are referring to? Thanks.
Apologies, I mean is this "big move", according to the chart circumstances, a move that will take place over a few days, one day (as in the jump we saw today), or is is that unknown? I was interested in the statistical reasoning behind the big jump and and dip we saw today. Is this simply a sell-off from some immediate gainers or something more that I'm missing? Thanks in advance.
@ mtcinc0 From a purely chartist/ trend-considering perspective, how do you explain the pattern today? I am intimately familiar with statistics but new to chart science. Your insight is appreciated in advance.
Yeah, I'm not sure about the specificity as a general screen either. We'll have to wait for further testing that directly tests that. For now we are going off of the FDA document for the CRC progression which had specific guidelines that basically adapted the test for that purpose. Other than that, we have the FDP levels from that same FDA document. Those showed promise for specific cancers and diseases but refinement is certainly needed.
With the current state of health-care, whatever that actually is, it seems we are headed toward a medically frugal environment. The cost of a test will most certainly come into play when considering diagnostic options. this will especially be important if the patients have to subsidize a portion of the bill. Dealing with insurance companies and being reimbursed for medical procedures, tests, supplies etc are the absolute most painful processes in the medical world: whether it be for small offices or large hospital systems. It is much easier to have a company reimburse you for a cheap test than an expensive one.
I enjoy my exchanges with you as well. They are always informative. Yes, the comparison between Onko-Sure and J & J is like that between apples and oranges. Was it RPC actually comparing themselves to J & J's proposed test or was it more of a defensive press release? From what I remember reading it seemed to be the latter. I think that the J & J proposed test story was released and people were raising questions of the usefulness/ marketability of Onko-Sure in an environment containing the J & J test. If you have any links, I would like to take a look.
Yes, I could definitely see it as a therapeutic monitoring test. However, again you run into the problem of it possibly only being effective at a later stage of cancer. Regardless, the late stage cancer market is huge. If it can be as effective as J & J hopes then is certainly worth the 51 million dollar development price tag.
Thanks in advance for the information.
My point was never that they were wasting money. It was that the argument of A company investing X millions isn't a good marker for how well a test will do. Now I understand that J & J is a well known company etc. However, well known companies make huge mistakes all the time. This may be slightly off topic, but Microsoft (one of the biggest companies in the world if not THE biggest) has had failed merger after merger attempting to suit its windows mobile software to some decent hardware. They cripple every company they go to. You will see the same when they merge with Nokia. Their software simply does not compete in the current market. You'd figure they could eventually get it right with all of the money and resources at their disposal. I digress.
If the J & J test can actually capture the cancer cells effectively then there can be great merit in this product. You are essentially performing a type of internal biopsy without the need for surgery. You can use the captured cells to grow your own colony and attempt to identify the specific mutation that the cancer cells contain. With the increasing information about cancer biology, we can hopefully identify a more specific treatment. Furthermore, with this test you should be able to identify the location of the cancer given the differentiation of the cells. But again, the specificity of the attraction to cancer cells has to be excellent.
I'm not quite sure what J & J has up their sleeve for this test. It is very interesting technology and there should be some use for it. We'll just have to see.
It CAN capture a single cell. If it can ISOLATE single cells, I can't even imagine how expensive the test would be to manufacture and administer. How can you guarantee that your sample of blood contains those few metastatic cancer cells? The only way to guarantee that you don't have cancer with this test is to literally wash the cancer trapping portions of the plate with the patient's entire blood volume. THIS test has worse screening issues than Onko-Sure. So, for this test to be worth the most likely high price you would probably have to somehow guarantee that there will be cancerous cells in the blood sample that is drawn for the test. These points are inarguable.
Furthermore, the argument of why a company would spend X millions of dollars on an "ineffective" test simply is not valid. You don't believe in ability of the Onko-Sure kit and they spent x millions of dollars on their test. Numerous companies spend x millions of dollars developing tests that may not work very well.
It is a fact that metastasis primarily occurs in the later stage of cancer progression. If you are looking for metastatic cells then that would be in...the LATER stage of cancer progression. It is possible that they are aiming this test particularly at cancer identification. In which case it would be an excellent test. However, it still cannot be effective in early stage cancer detection or identification. If it was meant for that, don't you think J & J would have touted it as a benefit in their press release? They can't because their test simply cannot due that. This is all basic cancer biology.
@Gold, Referring to the potential of the J & J test. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/89162?icn=ctc&ici=home-page-feature-box-89162
This is a test very similar to the proposed J & J test. What is the HUGE draw back to a test like this? What leaves the market wide open for a test like Onko-Sure EVEN if the J & J test or a test like this one is fully developed and available? The word metastatic. I'm sure that you understand the implications of this word, Gold. But, for those with a non-science background, the metastatic phase of cancer is when the cancer cells begin to "de-anchor" if you will and spread throughout the body via the blood stream. This is a slightly advanced to advanced stage of cancer. Therefore, a test like the one on the Mayo website or the J&J test would not be remotely effective as an early stage detection tool. That is why a test like Onko-Sure or one similar to Onko-Sure can still thrive in a market that contains these type of "cancer capturing" tests. Not to knock the technology, it is probably an excellent test for identifying and quantifying metastatic cancer cells. But it is only useful when cancer is beginning to circulate, at which point it could be at a stage that is very difficult to treat. Maybe it can be used for pure identification. In this case it would have to be EXTREMELY sensitive to identify at stage I or II. I'll have to look up the average number of metastatic cells in early stage cancer but my guess is that it is very low if even detectable/ present at all. FDP are present and detectable as soon as cancer cells/ tumor begins to develop and grow, which is why it can be used as an early stage detection marker. False positives etc aside, the core technologies in the Onko-Sure and J & J tests are completely different and allow for both to exist at the same time.
I'd have to agree with the smart trend on this one. I think today is more of a correction than squeeze on anticipation. We'll have to wait and see.
Can you please link me to the new S3 filing? Also do you know what we are looking time-line wise for the completion of the filing and the and the ability to exercise share selling by the lenders?
@ Gold, So basically, nothing official will come of this wrong filing in terms of penalties, correct? It is strange that they withdrew, but it didn't necessarily have to be for "negative" reasons. Is it possible that their plans from the original S1 filing changed? In this case maybe they wanted to give a revised, more accurate plan? Is it also possible that they were too busy to the very extended version of the S3 (the S1) because of the recent activity both financially and product/ marketing wise?
@ Gold, Won't the SEC ask them to file a new S1 then? Also, why was the previous one not approved?
@Gold,
"Why would they file and S3 when the SEC rules does not allow it? Was that just an error? I don't think so. If I know the rules, a CFO should certainly know the rules."
So you are saying that they knew they weren't supposed to file an S3 but they did it anyway? What is the benefit of that? Could you explain further?
@ GOLD, I have to look for the source on their manufacturing site. Off the top of my head I want to lean toward South Korea as one site, but don't quote me on that.
Do I trust RPC? I am not 100% sure if I do. I am well aware that they have to make themselves look as good as possible. However, I do think their test has the potential to make good money with the right PR and the potentially good Mayo clinic results.
Please don't use ONLY my advice to make your decisions. I try to provide as much accurate and factual information I can find. I try to analyze the articles and numbers given in those articles to the best of my ability. However, there is always the risk that Radient completely overestimated their New kit's accuracy, that the marketing team won't push this kit hard enough, that the company doesn't have a large enough supply of the kits, that the company gets de-listed, or even that the company goes bankrupt. All of these risks should be understood before investing. I personally think that if the Mayo results are what RPC is indicating them to be, then they could receive a barrage of orders that could turn this into a completely legitimate business, financially speaking.They have a few foreign factories that can be added onto in order to meet a large demand. They need that demand first!
Agreed that marketing is the issue. They can only push this edge with the proper marketing team. If they take the right steps, they can certainly realize their potential.
We'll have to see about the new test. The question still remains: do you think that Onko-Sure can replace CEA with its higher specificity and sensitivity;stage I/II detection; MUCH cheaper price; and with draw backs that are the same or similar to CEA? Regardless of how poor Onko-Sure is, it is better than CEA and will be further proven so in the Mayo trials. It seems to be a good bet that it will take CEA's business. Why not replace a current tet that has the same draw backs but cheaper and with better accuracy? Seems to be a no-brainer in book.
@ Gold Take a look at this link http://www.labtestsonline.org/understanding/analytes/cea/test.html . The issues with CEA in the media are the same with Onko-Sure. So, if Onko-Sure outperforms CEA head-to-head, don't you think that it could essentially take CEA's place on websites like this? If it simply out-performs the CEA test with the same if not similar draw backs, why can't it be profitable? The CEA test market is in the hundreds of millions. That would certainly be a huge step for RPC, regardless of their success or lack there-of in regards to the general screen test development/ sales.
Certainly interesting and concerning. However, I believe that is for the Old Gen test. If the New Gen test posts better results from the Mayo study RPC will release them. At that point we can reassess.
@ Gold, Apologies, I meant $149, http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=202965. If you look at my other posts, I wrote $149 as well. Those doctors fees will still be insignificant compared to the more expensive and similarly inaccurate cancer tests out there. Administration and collection fees might not be so high either if done in conjunction with your blood test. Those figures are to be determined. Maybe under the new health-care programs we will see some sot of subsidization. All of this remains to be determined.
I agree that the universal cancer markers available aren't as good as we would like. But trying to develop a "universal" cancer marker is equally as difficult as understanding what cancer actually IS in the first place. The only characteristics that are similar among the different cancers is their ability to replicate and grow without contact inhibition, ability to carry on replication without fears of telomere shortening issues, ability to vascularize (form capillaries/ blood vessels to neighboring blood supplies in order to grow), and anchor to parts of the body then break up and spread. The last two parts-vascularization and anchoring-are aided by FDP. So, Fibrinogen Degradation Products are the common link among the different cancers.
I agree that Onko-Sure could be better, but I maintain that, at its price point of $49, it can provide some very useful information when complemented with the other limited but also problematic cancer tests that we unfortunately are stuck with at this point of our scientific development. If the NEW test is as effective as the say, then you can definitely use this to determine the LACK of cancer accurately. The price of false positives (unnecessary imaging or biopsy) in those relatively few cases will be drastically outweighed by the money saved among those who were found to be cancer free. Obviously, this will work better for some cancers than others according to the OLD FDA submission data. Maybe the number of cancers increases with the NEW test, maybe not. The main thing Onko-Sure has going for it is its price.
Maybe they weren't aware of the better performance of the new antibodies until AFTER a comparison was made. A lot of times these things aren't known until AFTER trials with multiple antibodies are performed. According to research at the time of the development of the kit, they probably were under the impression that their original antibody was best suited for that purpose. Even with the most advanced modeling and binding site theory testing, certain things cannot be predicted until they are actually tested. Maybe this new antibody wasn't available until they made the new kit. I'm not exactly sure.
However, an antibody switch can certainly increase the specificity and sensitivity drastically. It is the main portion of the test. It is possible that the binding sites on this new antibody are more pure (less disfigured product per batch). Or it is possible that they are more specific for FDP (better FDP level detection). Or maybe they are less likely to bind other antigens (less false positives). All possibilities.
He was talking about the New test that is in the Mayo trials and so am I. The current test is the Old test, correct?
Oh, can you link me to that source? The conference call speaker said 95% specificity and sensitivity.
Although I haven't had a chance to look at your documents. That 95% specificity and sensitivity is for the NEW test. A test for which we have NO data yet. We'll have to wait for the Mayo results to see how true that is.
@ Gold, Thanks for all of that info. I haven't had much free time lately. I'll take a look at it soon and get back to you.