NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

IMO, with large german clinics/hospitals opening their DCVax-L phase III programs, combined with Dr. Bosch's two recent presentations in Germany, plus the HE program and of course the overall uptick in clinic openings, my point is that I think enrollment has likely been moving at an optimal pace since LP spoke in December. Setting aside accelerated approval for the moment, let's see an example from another company where "top line results" are expected following completion of enrollment.

Heron Therapeutics Reaches Target Patient Enrollment in MAGIC Phase 3 Study of SUSTOL®
-Topline Results Expected in May 2015
-NDA Resubmission Expected Mid-Year 2015

April 02, 2015 08:00 AM Eastern Daylight Time
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company, today announced that it has reached its enrollment target in MAGIC (Modified Absorption Granisetron In the Prevention of Chemotherapy induced nausea and vomiting (CINV)) and is in the process of closing enrollment of new patients at its clinical sites. MAGIC is Heron’s Phase 3 study evaluating the efficacy of SUSTOL® (granisetron injection, extended release) in the prevention of delayed-onset CINV following administration of highly emetogenic chemotherapy (HEC) agents.

“This milestone marks an important step in the development of our lead product candidate, SUSTOL, which has the potential to provide a safe and effective treatment option for the many cancer patients suffering from CINV”

This prospective, randomized, placebo-controlled, Phase 3 study compares SUSTOL plus the neurokinin-1 (NK1) receptor antagonist fosaprepitant and dexamethasone to the current standard of care for delayed-onset CINV following administration of HEC agents, ondansetron plus fosaprepitant and dexamethasone. The study has enrolled approximately 900 patients receiving various HEC agents, as defined by the 2011 ASCO guidelines, at approximately 200 U.S. sites. The primary endpoint in this study is the proportion of patients who achieved a complete response, defined as no emesis and no rescue medications, in the 24-120 hours following chemotherapy.

“This milestone marks an important step in the development of our lead product candidate, SUSTOL, which has the potential to provide a safe and effective treatment option for the many cancer patients suffering from CINV,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. “With our enrollment goal achieved, we will now turn our focus to collecting all study data as quickly as possible in order to report topline results in May 2015, followed by the resubmission of the SUSTOL NDA to the U.S. Food and Drug Administration (FDA) around the middle of this year.