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User Info Uh, That's Not A Conspiracy Theory; entered at 2021-11-02 17:21:51
Porter
Posts: 44
Registered: 2011-03-29 Emmitsburg, Maryland
I can't argue with what is likely a probable outcome. Maybe I am misconstruing something, but some are suggesting that there is tweaking or potential tampering with the process. At this point, everything could be on the table, but remember that even if these lots were released for use under a set of "specifications" that is not the end of the story. Manufacturing should be an iterative process where you go back and assess your initial specifications in your design. There you would look for interaction of effects. I worked on a process where it was found that a time frame in processing at an initial capture step (call it step #3) severely impacted product yield at step #22. It was seemingly random and appeared to have multiple interactions. Was the initial step a critical step? No. But it was later. Dozens of runs in a row with no issue. Plant changed staffing allocations and things slowed down a little. 2 hours difference at step #3 (always maintained in "control" and there was no data to suggest/support that small a time impact as the material was held for many hours longer at smaller scale. But it was there. I guess my point is: there are SO many variables that are unknown even in what you would call "tightly controlled" process and no one has the time or money to find a and know all of them.....but this is precisely why it is an iterative process and clinical trial data should be scrutinized. From my manufacturing background I agree with the host. To see this across 3 separate products is a huge flare. Perhaps this is part of why some high FDA folks quit as any booster is potentially loaded gun. Could it be intentional? Maybe but it doesn't matter because it could also just as easily be the reality of rushing ANYTHING out to millions of people without the proper testing/assessment. Again the screaming FLARE is that no one appears to be even looking. Not so long ago an actress said *******s cause autism. Right or wrong, people started looking at things. Fast forward: Dark times indeed.
2021-11-02 17:21:51