https://www.fda.gov/patients/fast-track-breakthrou
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Posted On: 01/06/2022 9:15:49 PM
https://www.fda.gov/patients/fast-track-break...gh-therapy
Judgement- many investors and management felt Leronlimab was a significant upgrade from SOC. I certainly do. If you read its a grey area that used judgement. There is no if its 5% 10% 30% better. It says in NOV 8th PR that cydy would like to be another option for MTNBC. I am glad they submitted data over 2 months ago because now seems like it should speed up process when cydy resubmits it updates survival data which even bashers and negative nancies can’t argue will be significantly better because right now data inclined they all passed at around 12 months. Its been been 4 additional months so it sill be a definitive increase.
Judgement- many investors and management felt Leronlimab was a significant upgrade from SOC. I certainly do. If you read its a grey area that used judgement. There is no if its 5% 10% 30% better. It says in NOV 8th PR that cydy would like to be another option for MTNBC. I am glad they submitted data over 2 months ago because now seems like it should speed up process when cydy resubmits it updates survival data which even bashers and negative nancies can’t argue will be significantly better because right now data inclined they all passed at around 12 months. Its been been 4 additional months so it sill be a definitive increase.
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