What is the reason why there may be exceptions? I am guessing the answer is there are cases where the benefits of fast approval outweigh the risks. See the American Society for Gene and Cell Therapies promotion of its Sep 23 policy summit agenda - you should get a flavour of how the FDA is gearing up to approve novel therapies:
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-415
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$1.10 |
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Mkt cap ! $1.250B | |||
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| 4 | 21024 | $1.09 |
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| Price($) | Vol. | No. |
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