Copaxone—entirely synthetic with no animal-derived feedstock—is easier than Lovenox to reverse-engineer and manufacture within the lot-to-lot variation of the branded product.
Well said. It is what I have been trying poorly to articulate.
While C is much larger and inherently thus more complex, given greater uniformity in the feedstock, IF MNTA can reverse-engineer the process and embed their IP in controlling the processes, they will succeed.
Maybe MNTA should turn to Coke and Oreo's. At least there they will not have to wait on the FDA for approval.
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
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