Pears,
Couple things.
1. My Trump reference was tongue in cheek.
2. Trump has not much time to study. Spends too much time on twitter or at Mar-Lago.
3.Agree with your assessment about detailed bead data/fda approval. The ONLY wiggle I can give ctso is that they believe EU, India et al offers a larger market than USA at much a much lower priced proving ground.
4. A friend of mine worked as a salesman for a Massachusetts company called Cytyc(Boxboro, MA). They invented a system called Thin Prep, which was designed to replace the pap smear.
At a 4th of July party sometime in the mid 1990's, he called me to his car, opened the trunk and pulled out a thin prep package and explained the concept. He explained his job was to advise doctors of it's potential. Even after it's later approval, it was a long slog before thin prep became the dominant screener for cervical cancer(soc). They were bought out by Hologic in 2007 for over 6B dollarsin 2007.
So Pears, I understand your argument completely, but I also understand the potential.