You believe the Stimuvax lung cancer study is taking longer to complete than expected, which means patients are living longer i.e. Stimuvax is helping patients live longer. This is the same assumption made by followers and believers of Cell Therapeutics (CTIC), Novelos Therapeutics and Genvec (GNVC), among others. Each of these companies conducted phase III cancer drug studies with survival endpoints that ran longer than expected. Each trial failed.
Bears will admit there's something odd about Stimuvax if/when Merck and Oncothyreon announce a statistically significant boost in lung cancer patient survival -- in other words if/when the phase III study is successful. Until that happens, those of us on the other side of the Stimuvax story are more apt to sharply discount the optimistic and assumptive modeling based on incomplete knowledge of the phase III patient enrollment curve. Bears are more likely to believe that lung cancer patients in both arms of the Stimuvax study were always more likely to live a lot longer than Merck and Oncothyreon assumed due to factors apparent in the older phase II study. This "delay" in reporting results isn't a delay at all.
Lastly, @given2tweet asks,
"Why has Merck
Drug companies invest in post-approval activities all the time before ever having in hand results from pivotal clinical studies. Prepping regulatory filings, investing in new manufacturing and hiring commercial/sales people can take a long time so almost by default these investments have to be started early. If a drug works, these investments can be accelerated; if a drug flops, companies throttle back, plans are changed, new hires are laid off. It happens all the time.Tuesday's column Six Drug Stocks Unworthy of Biotech Bull Market set the Hostile React-o-Meter aflame. "Peterpmf" was succinct in his criticism: "Go
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