It suggests to me that they want to have at least EU approval for sales, within two years. The initial job length being two years. Given that FDA knowledge is a desired request then that market is not the primary goal. So have the facilities validated for both primary and secondary manufacture and launch stocks ready to rock in less than two years suggests the next set of data is looking good. Again just my opinion here. Could be barking up the wrong tree.
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It suggests to me that they want to have at least EU approval...
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