headache...as far as time frame until we get some sort of independant verification, I don't think we'll see conclusive data out of Abbott or whoever for 6 - 12 months. Everyone I'm talking to is telling me that the process for testing a serum assay for general screening indication is ULTRA fast.
We're talking about simply issuing a positive or negative reading for each sample out of a large group of samples, and determining the sensitivity/specificity.
The specifics of trial design -- like how many arms and what arms -- will be up to Abbott, & will largely depend on how they want to position RECAF in the market. In light of what I said in my prior post about positioning RECAF as a "piggyback" assay at first, I wouldn't be surprised if they structured a dual-arm trial of PSA test vs. RECAF plus PSA. That data would give their marketing/distribution machine a ton of leverage compared to just a PSA vs. RECAF test.
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