I'm not certain what market ready means, but I bel
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Posted On: 01/09/2018 2:43:02 AM
I'm not certain what market ready means, but I believe that it means that they have the capability of producing the drug in commercial quantities in facilities that meet manufacturing standards approved by the FDA. Companies don't normally invest in such capability until they're at least entering Phase 2 Trials, and sometimes not until they're in Phase 3.
I believe because of OWCP's agreement with Amelia, they developed the manufacturing capability in time to do Phase 1 trials. It's very possible that Amelia was able to adapt a facility they already had available, so the cost may actually been less than if they had built a smaller facility only intended to be large enough for pivotal trials.
While the cream, and possibly even the sublingual tablet could be put into legal cannabis stores as they are, I believe the company at least wants them proven safe before any such move is made. That's the intent of Phase 1 Trials, so I believe when they've concluded, we'll get the word that in at least some parts of the world, these products are available for sale.
Gary
I believe because of OWCP's agreement with Amelia, they developed the manufacturing capability in time to do Phase 1 trials. It's very possible that Amelia was able to adapt a facility they already had available, so the cost may actually been less than if they had built a smaller facility only intended to be large enough for pivotal trials.
While the cream, and possibly even the sublingual tablet could be put into legal cannabis stores as they are, I believe the company at least wants them proven safe before any such move is made. That's the intent of Phase 1 Trials, so I believe when they've concluded, we'll get the word that in at least some parts of the world, these products are available for sale.
Gary
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