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Sunday, January 03, 2016 2:19:28 PM
For me that is an acceptible assumption as long as eyes and ears remain open for info and arguments to the contrary.
A further assumption that I have been comfortable making is that the reason for the scale-up now is either because there is some chance of an early approval, or they need to start now to have it fully funtional and approved by the time the FDA and EMA are considering approval. The demonstrated ability to mfg is a consideration for approval, and it may have been communicated to LP that it is a large consideration.
It could be a much longer effort to scale up mfg than myself and others have suggested in their posts. It could be a year long effort, an 18 month effort, or more. I don't know when they started spending the big $. Six months ago?
Gambling $100M+ with such an expansion makes sense to me. It increases the odds of approval and odds of early commercial success if approval is granted. (I also see now why Flipper was talking about the advantage in maintaining skilled staff etc at the clinics and mfg facility.) The whole trial was a huge gamble. This is no different in my view.
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