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Friday, May 31, 2024 8:34:49 AM
However, I agree with your assertion about FDA/SEC, so we are on same page my friend..
My guess it got approved without a committee of KOL’s/Panel , etc based on the ‘earlier version’ and the changes made( that allowed for approval)
Adverse Reactions
The most common adverse reactions ≥
Grade 3 (incidence ≥ 20%) were stomatitis, thrombocytopenia,
neutropenia, febrile neutropenia, anemia, and leukopenia.
Three patients died during LYFGENIA clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an….
“earlier version of LYFGENIA using a different manufacturing process and transplant procedure” (Study 1, Group A).
As you are aware, many New cell therapies have a ‘boxed warning’ that would scare the Bjesus out of a patient, but tell that to a sickle cell person and they’ll take the risk to live a ‘normal’ life vs. the The Consequences!
The fact they got Payers that cover Millions of folks is impressive, so 2nd half should provide tremendous revenue growth, we just need them to stretch cash run way ( thru better controls) and get the contract Mfg/lease issue behind them!!
File the K/ and Q’s and ambulance chasers will disappear..GLTA
![Bullish](/static/images/ih2-bull.png)
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