This relates to comments yesterday at the JDStox blog about FDA fast approval.
J&J, Pharmacyclics score 'breakthrough' coup with blockbuster hopeful ibrutinib
February 13, 2013 | By John Carroll
J&J ($JNJ) and Pharmacyclics ($PCYC) nabbed the FDA's new breakthrough designation for their cancer drug ibrutinib, a promising late-stage therapy that will be put in the hands of regulators later this year.
Lawmakers created the breakthrough category to accelerate a select group of programs through a quick review process, possibly shaving a significant amount of time off the slow and expensive development process. The government's idea here is that some drugs that have demonstrated significant promise in offering new hope to patients in early studies should make it to the market without being required to first complete the traditional three-phase development plan....