It's a Class 2 resubmission because BOT have to do a Human Factors Study. That requirement simply doesn't fall into the Class 1 classification. Law requires FDA to review these types of resubmissions WITHIN 6 month's, but as the FDA expert lawyer said on the webinar, usually the FDA take the full 6 months. That is the only reason BOT are not saying 6 months on the dot. Here's hoping for an earlier end to the 6-months, but there's no chance we're going to see anything within 4 months of resubmission.
Watch from the 27:55 mark:
Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-60
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Last
28.5¢ |
Change
-0.005(1.72%) |
Mkt cap ! $448.9M | |||
| Open | High | Low | Value | Volume |
| 30.0¢ | 30.0¢ | 28.0¢ | $1.405M | 4.899M |
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| No. | Vol. | Price($) |
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| 3 | 200490 | 28.5¢ |
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| 29.0¢ | 345394 | 4 |
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| Last trade - 16.10pm 04/06/2024 (20 minute delay) ? |
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Last
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Change
-0.005 ( 3.68 %) |
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| Last updated 15.59pm 04/06/2024 ? | |||||
| BOT (ASX) Chart |