I listened to the CC and that is EXACTLY what they will do. They are meeting with the FDA over the next week to find out what the most appropriate path to take is. Could be 90 days for the 510K, but could also take quite a bit longer if a PMA is needed, or additional studies are required. EXAS will obviously provide the FDA with all of their CLINICAL DATA over the past several years for Pre-Gen+. For the life of me, I can't understand how the FDA could think that a commercial lab test was a "medical device". Such a claim seems rather outrageous to me. Also equally puzzling, the FDA Letter was sent to EXAS and not LabCorp (LH) which actually conducts the test and does all of the sales/marketing aspects of the test. Seems like a "turf" war to me for the FDA, but we will know more when the quarterly earnings come out shortly, because EXAS will have met with the FDA by then and will have a much better understanding of what the FDA is looking for, and what the appropriate path will be. As Jeff Luber at EXAS pointed out, there really is no historical analog for this process. Not sure if the FDA's recent request will factor into ACS Guideline inclusion, since the FDA aspect is regulatory whereas the ACS is soley concerned with clinical data and getting the 70% of the CMS population screened for colorectal cancer. http://finance.yahoo.com/q/h?s=EXAS Today's Conference Call can be found in the above link. As always, conduct your own due-diligence.
Who said anything about people who took a position in this stock are "momo" traders? I'm an INVESTOR in EXAS. I own the stock in the low $2's. No need to trade this stock given the technology that it has for colorectal cancer screening.
Kind of difficult being a "bagholder" when you own a $4.80 stock in the low 2's. But hey, thanks for your concern. For someone that posted 24 TIMES on ET yesterday, I doubt that you do anything else but get paid by the post. You obviously spend so much time on ET that you can't be a trader, investor, or anything else but someone that plays on the Internet. Everyone on this website knows that you are a "nobody" that does anything but blow a lot of hot air. Tell me, does Baron give you a "Gold Star" when you get to your 4000th post? Has your Mommy left for work yet?
This is total politcal bs. I bet you the lobbyists that do work for the colonscopy companies clammored to the FDA to regulate this company to protect their business.
it looks like ed seykota's saying is proving its worth again: "Everybody gets what they want out of the market." in this particular case people wanted (company dealing in) sh$t so they got the sh$t...
I don't believe this really has anything to do with politics so much as it has to do with the fact that the potential Medi-Care coverage for this product is 40 MILLION people across 19 or 20 states. If you were a supervisor over at the FDA and someone at CMS contacted you about the status of "Pre-Gen+", wouldn't you want to review this lab test so as to make sure that your butt is covered, especially since it is going to be effecting 40 MILLION patients? The fact of the matter is that the company has been talking with the FDA for over a year now, but never wanted to waste shareholder's money pursuing FDA approval because: 1.) It really is much more important getting into the American Cancer Society's Cancer Screening Guidlines for Colorectal Cancer. If they don't get their screening test into the guidelines, it really doesn't matter whether or not the test is approved by the FDA. There are plenty of products out there that have FDA "approval" but are not in the ACS Screening Guidelines. It's ALL about getting into the GUIDELINES! and 2.) The FDA never approached EXAS with the notion that their "Pre-Gen+" test was ever considered to be a "home-brew" test, until now. Their policy must have changed. In any event, ( as per the conference call this morning ) the company will be filing a 510K shortly with the FDA and working with their contact there. I do not think of this as an antagonistic relationship; more of a collaborative effort. Furthermore, it is interesting to note that the "Letter" from the FDA was sent to EXAS, and not LH. That is pretty significant since it continues to allow LabCorp (LH) the freedom to market and sell the "Pre-Gen+" test to commerical customers, while EXAS continues along the regulatory lines of approval with the FDA. In otherwords, there will be a parallel product here. Again, it really is about getting into the revised guidelines for cancer screening by the ACS, due out in November ( so says the American Gastro Society ). In the meantime, look for results of the Itzkowitz study on Version-2 of Pre-Gen+ shortly. This will be my final post on the topic because I do not wish to be seen as some sort of a "pumper". I am simply an INVESTOR that believes in the need for cancer screening of the #2 killer in America of people over the age of 50, and I believe in the technology that EXAS has in their Pre-Gen+ test. Good Luck to all.