They are not reviewing the trial data. The FDA have accepted the science. They were obliged to list ALL of their concerns in the CRL to BOT (this is their legal obligation as per their guidance material) and we all know their CRL only contained minor admin issues about the instructions. Yes, they could still find some error or non-conformance around the instructions potentially, but you'd have to say highly unlikely if BOT have actually addressed each and every one of their listed concerns (which BOT say they have).
Ann: NDA Resubmission Accepted and Approval Date Confirmed, page-60
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Last
28.0¢ |
Change
-0.005(1.75%) |
Mkt cap ! $441.0M | |||
| Open | High | Low | Value | Volume |
| 29.0¢ | 29.0¢ | 27.5¢ | $1.258M | 4.481M |
Buyers (Bids)
| No. | Vol. | Price($) |
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| 3 | 102028 | 28.0¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
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| 28.5¢ | 200589 | 6 |
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| Last trade - 16.10pm 05/06/2024 (20 minute delay) ? |
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27.5¢ |
Change
-0.005 ( 3.37 %) |
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| Open | High | Low | Volume | ||
| 28.5¢ | 29.0¢ | 27.5¢ | 2415639 | ||
| Last updated 15.59pm 05/06/2024 ? | |||||
| BOT (ASX) Chart |