Hi All,
The sheer volume of posts here prevent me from monitoring continuously, but I owe folks like Ocyan, Hirogen, and Clarksterh greatly for fortifying my belief that IMPACT would ultimately prove successful and that Provenge would be approved. I have some knowledge of statistical methods, although not at anywhere near their level. When I started to follow DNDN after the failure of the 2007 data to prove efficacy using time-to-progression as the primary endpoint, at least I knew enough (about the difference between randomized experiments and observational studies) to be persuaded by the 2007 post-hoc analysis showing improved survival in the treatment arm.
Back on 4/29/2010 Ocyan wrote, in post
344318:
"Early data from P-11 already showed statistical significance for reduction (sic -- O. must have meant an increase) of PSA Doubling Time. The next clinical endpoint being tracked for is Time to Metastasis. There are a number of research works indicating that PSADT is a strong predictor of metastasis. This means that the likelihood of success for TTM is very high. Indeed, even with only 16% patients showing metastasis in 2006, the hazard ratio was already 0.73. This will improve with time. I believe that TTM for P-11 will come late 2011 or early 2012 and the hazard ratio will be much better than 0.73 then. This would situate Provenge in a good position to run another trial for label extension. If Circulating Tumor Cells turns out to be a good surrogate endpoint, that will speed up the process significantly."
Has Ocyan, or anyone else, come up with a more current estimate on when P-11 (which I am assuming is synonymous with PROTECT) data will be available? Anyone think that the data from P-11 could be so good that the company files earlier than then for an expanded label indication?
TIA,
--owlinkfan