goodman i was referring to your 1st and 2nd bullet points on the post. Regarding Abbott, I have a feeling the company obtained a high royalty rate in exchange for a low upfront. They hinted at this in the "Discussion P.R" if you read closely and I posted it at the time. Second of all, we only saw one payment from Abbott. In either the "Discussion P.R", the Abbott P.R, or the filings they say there are milestone payments (that's plural) and then royalties on sales. If we knew more about the size and amount of milestone payments, as well as the royalty rate, we could talk intelligently about the deal....but at this point we're both just guessing when we say BOCX got the shaft and the next deal will be better.
Regarding your other bullet points from the post...You've got to consider each indication separately. You've got to stop thinking about it as "approved" or "not approved" -- this product has many applications ("indications), each of which have very different regulatory hurdles, markets, and clinical procedures.
For the general screening indication, since RECAF is the universal test it will be given before, not after the PSA. The PSA is the localized test. So in other words, if RECAF works as well as the data published the general screening indication would mean it is offered to EVERYONE as part of a standard blood test (ie the nurse asks "Do you went a HEP-C test?" "Do you want an HIV test?" "Do you want to try this new RECAF test?"). Patients who turn up positively can opt for additional tests to "zero in" on the cancer, including the popular serum assays, mammagrams, full body scans, etc.
In this scenario PSA would still be administered at the general screening level to the appropriate demographic (ie males age 40+). That goes for the other serum assays as well. RECAF would serve as a catch-all for the dozens of cancers for which there is no serum assay currently.
Keep in mind the data has to REALLY HOLD UP if we are to become a general screening assay like HEP-C, TUBERCULOSIS, HIV, etc.
As for other indications, RECAF will be used differently. I have spoken to folks at the lab that refer to a "combination use" indication which I have posted about a few times. It involves using RECAF with the PSA to enhance sensitivity/specificity. The tests simply become "paired," just as the PSA is paired with the Gleeson test in virtually all practices nowadays. For this indication Abbott would run the data on a sample set 2 times...once with PSA, once with PSA + RECAF. Sensitivity/Specificity would be compared across the two groups to determine if adding RECAF to PSA improves the PSA by a statistically significant margin (alpha = .05 always). This can be done with CEA and all other serums of course.
This indication is similar to the general screening indication because it might not require a PMA (ie; only 510k which is super, super quick).
All post-therapy diagnostic indications (ie followup, relapse, etc) of RECAF will require multi-year trials and PMA's...no doubt about it.
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.
