This has been addressed somewhat, but the current effort and plans to expand capacity is what most companies due during PhIII. The most conservative practice would be to have only capacity for trials until approval. However, if approved much time would be wasted scaling manufacturing and getting it GMP approved by FDA, which itself is a torturous process. It could delay sales, and helping patients, for more than a year. Some companies in this situation put in place a lottery system to see who gets limited drugs. So, if at all possible companies must build out facilities in the hope of approval so sales can proceed soon after approval. For example, Dendreon spent over 100 million building out its first manufacturing plant before PhIII was complete. If could and does all go down the tubes if approval is denied. So, is expansion a vote of confidence that NW believes dVac-L will be approved. Well, I guess you could feel that why, but it is just what must be done if a company wants to hit the ground running. One thing that we do not know is the details of the actual manufacturing process and the degree that Cognate would have to physically expand facilities and staff. This would tell us something about how good of a deal Cognate is getting. I suspect a good one, but that is ok with me. As much as I hated Dendreon as a former investor, they even publish floor plans for the manufacturing plant.
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