Dianne should shut her trap if she does not know what she is talking about. The Canadian and EU assumptions are wrong based on China--that was an idiotic assumption, leading me to believe her knowledge is limited there too. I did a significant amount of DD on this, but not going to bother looking up a year old post. One of the main (and many) problems with China is the CFDA takes a far longer time and process cumbersome. They do not prioritize drugs in order of importance, so a generic aspirin approval would take precedence and slow-up a breakthrough cancer treatment if before it in their queue. China also has big time problems with contamination in processing too (no surprise) so imports a lot from GMP facilities overseas (and exports "bath salts" to our kids here). I believe she is incorrect about not accepting data from other trials--particularly if approved in their own countries.
Of course, in our case, our drug(s) have neither been approved nor as it turns out, do we have GMP approval as of yet.
Health Canada is cheaper, faster, and does take US data. Used to have stock in a biotech company there, so know it pretty well. They operate with common sense, less BP political influence, so the Tmax may be a labeling issue there. They have a bigger per capita opioid problem than we do. Health Canada is not at all analogous to China.
I'm not sure of the particulars of the EU per cost, but again they are quicker (in general) and easier. I'm pretty sure they accept US data--that's one for some DD.
Well off again to do more cleaning/trashing, now that the tow truck came to pick up and trash our new car...or maybe something to mellow the nerves first, lol. My wife saw a snake in our piano so closing off that entire room, the floors have turned to rotting wood, and the only ones enjoying the pool are the sunbathing mosquitoes who like to swim in mud. Everything on my first floor destroyed. Never would have thought it would my best investment of the year to spend $350 on FEMA flood insurance, but will pay out 1000x times that (assuming the government doesn't try and ream me--they would never do that). ELTP--didn't watch it for over a week now, but upon this check-in is right now about exactly where it was before the storm. Missed out on all the .003 daily action. Two weeks ago, I was a happy camper, now, I'm just a camper in bad need of a shower. Probably won't be posting for a long while right now, but obviously, doesn't need my "help." GLTA,
Maz
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