Tuesday, May 26, 2026 5:34:41 PM
You probably should have labeled your “Analysis” section as "Speculation".
The phrase “fatal issues that have not been successfully dealt with” is the problem. An issue is only fatal once it actually kills the application. Until then, it may be a potentially fatal issue, a major objection, or an unresolved material concern.
The fact that the MAA has not been rejected proves only that it has not been rejected. It does not prove every potentially fatal issue has been successfully dealt with.
The phrase “fatal issues that have not been successfully dealt with” is the problem. An issue is only fatal once it actually kills the application. Until then, it may be a potentially fatal issue, a major objection, or an unresolved material concern.
The fact that the MAA has not been rejected proves only that it has not been rejected. It does not prove every potentially fatal issue has been successfully dealt with.
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- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
