I put together this timeline with info I took from Southern Cross Equities Report May 2011:
cheers
Birdseye -all looking good with NASDAQ listing and some of the the info below due soon!
-Phase 11b Trial (60 patients) recruitment to be completed by June 2011.
-Phase 11b interim data available July 2011
-Phase III (800 Patients)to start shortly - in Q3 2011-September Q
-Phase III CVac?s pivotal yield?s interim data late in 2012.
-Phase III final data set in late 2013 or early 2014.
-Marketing approval by late 2014 with commercial launch in 2015.
(end of timeline)
More details of the above (extract from Southern Cross Report May 2011):
Phase 11b Trial recruitment to be completed by June 2011.
In July 2009 PRR filed its IND application with the FDA to conduct a 60 patient Phase IIb clinical trial
of CVac in the US (60 patients)the first patient was enrolled in July 2010. The trial appears to
have proceeded quickly since then, with PRR expecting recruitment for the trial to be complete by
the end of June with interim data available next month i.e. July 2011.
Phase III to start shortly
There is now a clear pathway to Phase III and regulatory approval. PRR is also preparing for an 800-patient Phase III trial to be conducted in Europe, US and Australia that will commence in Q3 2011
CVac?s pivotal yield?s interim data late in 2012. As with Phase IIb, the Phase III trial of CVac will only recruit patients in remission, and will randomise the patients to either CVac or standard of care, measuring the months in which the patients enjoy Progression Free Survival as well as Overall Survival.
PRR expects to be able to do an interim analysis of the data by late 2012 or early 2013, with the final data set in late 2013 or early 2014. We expect that regulatory filings with
the EMA and FDA would follow, on a six-month review timeframe. This could lead to marketing approval by late 2014 with commercial launch in 2015.
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