Yeah, I would not put much stock into that, my man. Generally speaking, accelerated approval (approval at P2) is granted for drugs that meet an area of significant unmet clinical need. Vaxinia has demonstrated no differentiating characteristics thus far that would specialise it for a specific sub population of bile tract cancers. There are a couple additional considerations for Vaxinia and Bile Tract cancers: 1) not a common cancer, so cases are low; 2) many compounds in clinical trials competing for viable patients to test; and 3) there are numerous approved drugs for bile tract cancers.
Gemcitabine and Cisplatin have overall survival rates of roughly 11 months, so even if a phase 2 trial of sufficient size to be statistically robust was to have all patients recruited at day 1, it would take at least 12 months to start showing a survival benefit. Naturally, recruitment would be slow because rare cancer and competition among other compounds undergoing clinical testing, so this pushes timelines out further.
I am forming the opinion that a P2 Bile Tract trial won't even get off the ground. As @BirdDog66 points out, the patent cliff is fast approaching and the timeframe to capitalize commercially diminishing.
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Yeah, I would not put much stock into that, my man. Generally...
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