BOT - Anything but charting, page-8308

definitely still a risk but quite low. maybe some people are also true to the sell in may go away approach :/

for those interested there's a FDA study tracking 12 years of FDA NME applications (302) and FDA rejections (151 of 302) even of those receiving CRL for safety 62% were approved, for efficacy only 31% approved. and of thre original rejections labelling issues were only 15% of original rejection reason.

for the study the "drugs never approved" due to labelling was zero. this included labelling as a standalone (instructions) and labelling related to chemistry manufacturing and control


can't paste a link but if you search DOI 10.1001 / jama.2013.282542 the article is titled "Scientific and regulatory reasons for delay and denial of FDA approval for initial applications for new drugs, 2000-2012" with Sacks as primary author