Monday, March 16, 2020 4:51:03 PM
And interesting catch comparing the two presentations. I had earlier overlooked that small, but possibly critical language. What we do know is that pathway 1 presented the "biological burden" noted by Dr. Hsu which forced the exploration of alternative approaches. Per Mar presentation they appeared to be moving out w/scale up at CDMO 2 for an enhanced alternative approach. Now this should remain a bacterial approach as per EA in the annual letter to shareholders he noted that they have been exploring a new enzyme for the enhanced process/pathway 2 which could also be applied to baseline microbial pathway 1.
I cannot answer why GMP batch production at CDMO would even be commented on as if it were an option. At this point I was under the impression that we were only waiting on the cost and yield details of the new enhanced pathway 2 approach as they finalized the parameters for batch manufacture. It is unnerving to see "if needed" as opposed to "CDMO 2 or alternative CDMO partner" thus implying manufacturing w/a caveat that they may ID a better partner to produce the goods. They have no in-house scaling capabilities to even satisfy their trial's API requirement.
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