Not sure if you are saying mfg is the cause of the hold, but, I do not think so. And, if not, what is the relevance of this discussion? I really appreciate the majority of what is posted on this board. But, I have to say I am just not following the logic of the mfg patent stuff as patents do not typically play a role in this area and certainly do not play a role in timing of use of processes, FDA approvals do, and, FDA approvals do not interfere with patents either, they are separate processes unto themselves with the FDA approval the more important of the two as mfg patents tend to be relatively easy to circumvent, which is why it is not a prevalent practice, though in biologic processing there are more due to the relative newness of the technology, which is starting to become much more widely understood and used.
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