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How Long Does It Take To Put Together A New Drug Application After A?
Theoretically, the length of the Phase 3 clinical trial will be determined by the epidemiologists and biostatisticians that are analyzing the running data. Together with the basic scientists and medical scientists involved in the clinical trial, t would have designated a pre-determined p-value, such as less than or equal to .05, where the vaccine might have had a successful outcome versus the non-vaccine control. This variation to a typical Phase 3 clinical trial carries some risk because a smaller population of patients is used and a “significant” versus “highly significant” p-value. And second, a smaller number of testees also means a shorter duration clinical trial and potential long-term effects might not be detected. Given the contagious nature of COVID-19, the risk of a speedy Phase 3 clinical trial might be warranted.
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This is assuming that most launches proceed without problems. Most companies launch at least 1-2 drugs, have more than enough information, and have a plan already in place for the launch. The companies that have the most trouble in this arena are generally based on one drug being delayed. There are numerous reasons why a drug is delayed; there are several legal and regulatory hurdles that can be thrown in a company's way along the way; the pharmaceutical industry isn’t known for being patient-centered; there aren’t all the resources a drug company typically has; etc. This is how important transparency was at GSK. One of the most visible examples of how important transparency is to GSK is the release of the GSK Financial Statements that were released in 2012. One of the first things a company has to do is to provide investors with timely information about the.