"Last night, Janssen (in conjunction with Pharmacyclics) filed a Phase 4 Open Label Treatment Protocol for patients with relapsed/refractory mantle cell lymphoma (MCL) on www.clinicaltrials.gov. This early access program (EAP) is designed to allow use of single-agent ibrutinib to treat RR MCL patients that have no option and cannot enroll in a clinical trial. Currently, there are no RR MCL studies with ibrutinib underway - there is only a front-line MCL trial that is still enrolling patients. Traditionally, a pharmaceutical company, such as JNJ, will open an EAP within 2-3 months of filing for approval with the FDA. Therefore, we now expect that the ibrutinib filing will occur in Q3:13, approximately 3-6 months ahead of the year-end, publicly scheduled BLA. We believe that the FDA Breakthrough Therapy Designation (BTD) is, therefore, moving quickly along, and that formal approval will occur before the end of 2013 - roughly 6-9 months ahead of consensus expectations. In our view, this is a major positive for Pharmacyclics and is not discounted into any Wall Street forecasts, even the most bullish of opinions. We expect the consensus timing and estimates will rise as soon as this information is further disseminated. We had believed ibrutinib would be approved in early 2014, ahead of anyone on the Street. Based upon this new early access program and related timing of events, it seems that even we were too conservative."The key takeaway is bolded. Note the framing of "6-9 months ahead of consensus expectations." It would seem because of breakthrough therapy designation, Pharmacyclics' process is moving well
ahead of anyone's expectations by a material pace. Doesn't it appear the FDA has gotten behind PCYC in a big way.
How much is the FDA behind Provectus and PV-10?