Neurocrine’s FDA Rejection Bodes Well For Sepracor
Folks…I’ll say this until I’m blue in the face, because it’s really important. Don’t let ignorance of FDA’s approval decision-making processes and recent history be an excuse for an NME approval delay. Investor’s–who’ve crushed Neurocrine’s stock by well over 50% as I write this–will not give you any slack, as well they should not. Ignorance of facts is never an excuse for failure to achieve the best possible regulatory outcome. That’s why I’ve authored FDA’s Approvable and Related NDA/BLA Actions. It’s a comprehensive look at the hows and whys of relatively recent FDA approvable decisions that shows you where FDA dings for program deficiencies and how to manage a program to maximize chances of a first-cycle approval. Learn from past failures, so you’re not destined to repeat them. Enough proselytizing for now. If you’re an investor long in NBIX don’t panic yet. Consider selling at least a portion of your long position to lock in a capital loss and re-buying the stock after the situation becomes clearer (and after at least 30 days have elapsed to avoid a wash sale).
