Ah grasshopper yes I forgot about that one,
As far as a bio-statiscian is ever concered CVAC's Phase IIa trial did not meet the 15% objective becuase they used the incorrect denominator. They should have used 28 NOT 21.
There were 7 drop-outs due to disease progression. A 25% drop out rate is also quite material. It is 'intent to treat' analysis that one needs to consider so as to prevent bias which blatently occured in CVAC's phase IIa trial results.
IMO this is why Biomira chose NOT to progress CVAC and why a larger and molre definative phase IIb study is now required.
If one reads the DNDN trial protocol they even state that "patients who elect to come off study without objective disease progression (eg, for increasing PSA) were considered to have disease progression at the time of study withdrawal".
Rgds
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