GREY:ATBPF - Post by User
Comment by
PoorOpinionon Jan 19, 2018 5:23pm
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Post# 27397967
RE:RE:RE:RE:RE:RE:Anybody considered the rough ride CINODS had?
RE:RE:RE:RE:RE:RE:Anybody considered the rough ride CINODS had?But the problem is "superficial thought processes" do occur at all levels. Here's an example. I worked at a biotech that had an antibody based product going thru the approval process. Things were generally fine until one day a completely unrelated company, with a completely unrelated antibody, to a completely unrelated target, in a completely unrelated medicinal field, injected six health volenteers and got an enormous cytokine storm response. Massive swelling, necrotized tissue, disfigurement, amputations, near death, the lot.
The response turned out to be very specific to that drug but when the alarm bells went off at the regulators the superficial response was to lump our drug in with that drug and make a whole new set of demands on us. You could argue it was a reasonable safety response but it was also very unsophisticated.
Its reasonable to think the hangover from naproxcinod still exists, I'm arguing in favour of stupidity I know. If these trial results dont turn out to be the tipping point we expect them to be its worth considering why. If they do then who cares we're all rich!
I got something out of this exchange though. I have held ATE so long that I tend to just look at new developments on thier own merits. It good to have a reference back to some possible concerns others might have and look at what Antibe have been doing in light of that.