Tuesday, August 12, 2025 4:12:30 PM
The problem is still the EDEN, until it's approved to manufacture our vaccine the company doesn't have a commercial production facility that an inspection team would say could meet the needs if the FDA approved.
The inspection of the commercial production facility is a part of a BLA filing, we may use contractors to make the vaccine but it must be done with equipment they'll approve. The UK accepted the 20 tiny cleanrooms as meeting that requirement, they could submit to the FDA proposing the same, but I believe they know they'd be turned down. The company won't say it, but their actions speak louder than their words.
Gary
The inspection of the commercial production facility is a part of a BLA filing, we may use contractors to make the vaccine but it must be done with equipment they'll approve. The UK accepted the 20 tiny cleanrooms as meeting that requirement, they could submit to the FDA proposing the same, but I believe they know they'd be turned down. The company won't say it, but their actions speak louder than their words.
Gary
Bullish
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