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Re: Kag post# 2210

Wednesday, 02/15/2006 10:34:52 AM

Wednesday, February 15, 2006 10:34:52 AM

Post# of 30387
Kag: keep in mind that RECAF is not a replacement to PSA or any of the other existing cancer markers for the simple reason that it is not specific to any particular type of cancer. for this reason I foresee the trial design for general screening indication as dual arm, PSA vs PSA + RECAF, rather than PSA vs RECAF. IMO RECAF will be similar to the Gleeson test for prostate cancer, used in conjunction with PSA as an accuracy booster. This goes for the other cancers, too, and it seems like this route opens the door for partnering with rather than competing with the existing diagnostic co's. That is a huge plus.

It is conceivable that RECAF could be used as a standalone test in conjunction with the RECAF imaging technology they're working on (the latter to pinpoint locale of cancer), but I'm not sold on the economics of that quite yet. It just seems like that route could get expensive unless RECAF shows bulletproof accuracy in further testing.

In my opinion the biggest risk to this investment is not failure of RECAF, but instead, the clinical indication that Abbott chooses to pursue. If Abbott decides to pursue RECAF as a post-treatment, cancer recurrence marker or as an early stage predictor marker we are very screwed because a PMA and very lengthy trial will be required. I don't mind Abbott pursuing those indications down the road, but we absolutely NEED them to start with the general screening indication. The company has said time and again that only a 510k will be required as opposed to a PMA, and this implies that general screening is the preferred route. That would be a very fast and easy trial that could get us to market sometime in late '06 or early '07 in the best case scenario, with data coming in 6 months or so before product launch (and as I've stressed many times data release will be the big mover here)

Take care,
BOCXMAN







DISCLAIMER: NEVER ASSUME INFO ON MESSAGE BOARDS TO BE ACCURATE. ALWAYS DO YOUR OWN DUE DILIGENCE. DON'T BUY STOCK BASED ON THIS POST OR ANY OTHER POST. I OWN A LONG POSITION IN THIS STOCK AND THEREFORE I AM BIASED.

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