30%? Bullocks
- BLA resubmission addressing all of the issues identified in the CRL accepted by FDA, meaning FDA view is MSB have satisfied all the elements of the CRL
- additional and astonishing real world 4 year survival data results
- 4 person FDA Inspection team over 10 day period passed the manufacturing facility in Singapore with flying colours and NO FORM 483 issued.
- ODAC 9-1 in favour
- Unmet need and no other effective medicines for children with aGVHD.
- FDA is approving stem cell products left right and centre.
IMO
Approval incoming!
2023 The Final Countdown, page-1973
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$1.13 |
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| Open | High | Low | Value | Volume |
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| 5 | 94863 | $1.13 |
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