Industry norm would be for Abbott to source this out to third party reference labs for large sample testing. The data will then, as Abbott indicated, be published and more importantly, it will be used to form the basis of the first 510k that Abbott will hopefully file with the FDA. Of course, before they send it off to the reference labs they must develop the assay for the ARCHITECT. I've posted that they are nearing completion and have enjoyed success with this part of the process. So hurdle #1 most likely won't bring us down. Hurdle #2 -- the reference labs like Quest, Joli, Universities, etc -- will determine the fate of this company. The independant data they produce will determine if RECAF is for real and whether this stock deservers a $200 - $500 mil market cap or a $2 mil market cap (we would trade for pennies if the data was bad).
Keep in mind that all of the above assumes that Abbott will go the 510k route as opposed to the PMA route. Both BOCX and Aurelius have emphatically told me they believe a 510k is sufficient, but despite what they say the FDA and Abbott will determine regulatory strategy for RECAF -- not BOCX!
If we filed a 510k we could literally do the "trial" in a matter of weeks -- it's not even a trial. The reference lab will simply run RECAF against a database of known healthy, malignant, and benign tissue. The results are obtained very, very quickly.
Now, it is virtually impossible to imagine a scenario where the FDA would require a PMA for the general screening indication but if they did, we're looking at a whole other process. PMA trials can years, and then there is the 6 month decision time plus 3 - 6 month objection period, committee oversight period, etc.
The general screening indication will most likely be a 510k as the company has been asserting, but most other indications will require a PMA. These include indications that have an element of time to them, the two biggest being:
- RECAF to monitor for recurrence of cancer after radiation/chemo/surgery/etc
- RECAF as an early stage cancer marker...ie as a predictor of cancer
Don't expect these indications any time soon. But if Abbott is determined we could see an FDA approved RECAF assay for the ARCHITECT system (label = general screening) in 2006. We could see data as early as the first half of 2006.
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.
