<<Teva has annual sales of about $14B. If Teva’s Lovenox ANDA has been re-characterized as a 505b2 NDA, this in itself would not meet (or even come close to) the materiality threshold requiring Teva to disclose it to investors.>>
TEVA's net income is under $1 billion. Wouldn"t the effect on net income be greater since revenues would be reduced and expenses increased if TEVA's drug were approved as other than a fully substitutable generic?