Thoughts still bubbling around my head from Friday
- if the relationship with the FDA was so collegial then I would have expected the FDA to say 'we won't be taking any RWD onboard no matter how compelling, if you pass the pre-approval inspection we're going to still need a RCT for any level of approval' at the point they indicated that the potency assay was 'reasonable'
- at this point MSB would know that it's RCT or bust - instead we've spent another near two years and burnt $100m odd waiting for data that was never going to be accepted whilst hanging our approval on Dr Marks stepping in to overrule his own dept which given the last time he did that it made international news with controversial results he was probably very unwilling to do.
Essentially we've been along for the ride with MSB betting that RWD would be accepted - that the FDA would change their stance and the FDA said like Margaret Thatcher we're 'this lady's not for turning'
Thoughts still bubbling around my head from Friday- if the...
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Last
$1.18 |
Change
0.090(8.29%) |
Mkt cap ! $1.324B | |||
| Open | High | Low | Value | Volume |
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| Price($) | Vol. | No. |
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| $1.18 | 69778 | 7 |
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| Last trade - 14.13pm 06/05/2024 (20 minute delay) ? |
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Last
$1.15 |
Change
0.090 ( 5.63 %) |
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| Last updated 14.34pm 06/05/2024 ? | |||||
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