Feller, I believe market ready means even more
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Posted On: 03/07/2018 9:26:02 PM
Feller,
I believe market ready means even more than you've suggested. I believe through their partnership with Emilia they have a production facility making the cream they're using in the trial, and capable of making commercial quantities of the cream, and the facility already has full approval to do so. I'm uncertain, but I believe that the same thing might be said for the sublingual tablet.
I cannot speak to the sophistication of the manufacturing process needed to produce the cream, but I do know that many drug production manufacturing facilities cost tens or hundreds of millions to create, and often manufacturing concerns delay overall drug approval as the data is deemed sufficient, but the manufacturing facility doesn't meet FDA criteria.
Gary
I believe market ready means even more than you've suggested. I believe through their partnership with Emilia they have a production facility making the cream they're using in the trial, and capable of making commercial quantities of the cream, and the facility already has full approval to do so. I'm uncertain, but I believe that the same thing might be said for the sublingual tablet.
I cannot speak to the sophistication of the manufacturing process needed to produce the cream, but I do know that many drug production manufacturing facilities cost tens or hundreds of millions to create, and often manufacturing concerns delay overall drug approval as the data is deemed sufficient, but the manufacturing facility doesn't meet FDA criteria.
Gary
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