Friday, February 14, 2020 8:12:56 AM
Remember how that one started. The previous vendor who was suppose to be caretaking the cells Lohr used, turned over a pleomorphic mess. Then Eurofins had to clone em to get the cells back to a stable(?) cell line. Which would give the FDA a pause: Are the cells Lohr used exactly like the cells in the MCB? Yet another vote against a Phase 2b if they are not.
As you state, Kenny had to do nothing. And if this were still the 1960s it could be argued cloning is time consuming. But today with high speed thru-put gene sequencing it is not. It was not a strain for Eurofins to do it. Neither would they consider it a great accomplishment. Rather just business as usual.
Actually that's almost a non-accomplishment. Didn't Lohr use encapsulated cells in 1999? The process on how to encapsulate was already known. The only thing AN had to do was figure out how to go from bench to bulk under GMP conditions. Who knows what Lohr's source did. Yet another thing the FDA would want to know.
Let's be fair to Kenny. He did spend a lot of time in Thailand watching the cells grow. Between that, and a little down time on the Thai beaches it probably was a grinder for Kenny.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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