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DragonBear

02/02/20 3:15 PM

#114793 RE: concordia #114773

Years of hard work doing what exactly?

The cell line is the exact same as the 20 year old line used in the previous CT otherwise its guaranteed the IND will be rejected.



Recall that EFINS was headed a pleomorphic mess. Where they had to make a clone of the cells stored from Lohr's days. How unstable and pleomorphic were the cells that Lohr used? Unknown. Did they produce the same amount of enzyme? Is the enzyme content produced by the old/new cells constant once implanted in the human body? Were Lohr's cells GMP manufactured by today's standards? Other variables?

It could be argued that although the genetics of the plasmid inserted genes are identical, what Lohr used is not exactly the same as being proposed for the mythical CT. Yet another reason for the FDA to reject a Phase 2b.