Hmm! Hate to see this for people! Also will the price suffer? ( that’s secondary to the people question )
$bluebird bio (BLUE.US)$ FDA Investigating Serious Risk Of Hematologic Malignancy Following Skysona (Elivaldogene Autotemcel)
Benzinga· 23 mins ago
WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancy, including life-threatening cases of myelodysplastic syndrome, has occurred in patients treated with SKYSONA. Patients have been diagnosed between 14 months and 7.5 years after SKYSONA administration, and the cancers appear to be the result of the SKYSONA lentiviral vector, Lenti-D, integration in proto-oncogenes. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated [see Warnings and Precautions (5.1)].
Benzinga· 23 mins ago
WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancy, including life-threatening cases of myelodysplastic syndrome, has occurred in patients treated with SKYSONA. Patients have been diagnosed between 14 months and 7.5 years after SKYSONA administration, and the cancers appear to be the result of the SKYSONA lentiviral vector, Lenti-D, integration in proto-oncogenes. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated [see Warnings and Precautions (5.1)].
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Jaguar8 : That is the really the accompanying risk of being ina clinical trial. This kind of adverse events is just troubling. I wonder how high their attrition rate is
Trytosaveabit OP Jaguar8 : Yeah I know! It just sux! You have a drug that really helps just to find out later it can add to the already bad situation! Grrr
Jaguar8 Trytosaveabit OP : True. Some subjects even die
Trytosaveabit OP Jaguar8 : Yup! My Mom was in a trial!
Jaguar8 Trytosaveabit OP : and what happened?
Trytosaveabit OP Jaguar8 : She’s gone! Hehehe
Jaguar8 Trytosaveabit OP : Because of the trial?
Trytosaveabit OP Jaguar8 : It’s hard to say for sure! It was right at very beginning of Covid! She was doing great! Family came to visit and found after the fact they were sick! Mom ended up in hospital and after Covid symptoms were know! I looked back at what happened with her. And i believe Covid was what actually caused her death! Compromised immune and then sick family visit! And her symptoms were 100% Severe Covid symptoms
Jaguar8 Trytosaveabit OP : Oh we were in the same situation. I was infected with Covid in 2021 at Stanford which made e go thru heart and renal failure and went comatose. I had worse than poor prognosis that time. So most likely the Covid was the final straw for your mom
Trytosaveabit OP Jaguar8 : Yes I’m in 100% belief of that!
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