question on fda scathing public letter As chrac
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Posted On: 03/24/2022 11:02:52 AM
question on fda scathing public letter
As chracterized by fierce biotech:
https://www.fiercebiotech.com/biotech/cytodyn...ob-to-fill
The fda letter states cytodyn trial failed but it was my pea-brained understanding that the fda letter was based on partial data results and there are highly redeming results in that specific leronlimab trial when the full data set is considered.
Further, our firm cannot/has not corrected the record because they feel addressing the fda letter inacuraccy is not politically correct, considering the power of the agency. In other words, our firm fear retaliation, which I cannot disagree with thier judgement.
Can someone with a more powerful brain indicate your take on this point? I just need some validation for my aforementioned pea brain.
BBQ
As chracterized by fierce biotech:
https://www.fiercebiotech.com/biotech/cytodyn...ob-to-fill
The fda letter states cytodyn trial failed but it was my pea-brained understanding that the fda letter was based on partial data results and there are highly redeming results in that specific leronlimab trial when the full data set is considered.
Further, our firm cannot/has not corrected the record because they feel addressing the fda letter inacuraccy is not politically correct, considering the power of the agency. In other words, our firm fear retaliation, which I cannot disagree with thier judgement.
Can someone with a more powerful brain indicate your take on this point? I just need some validation for my aforementioned pea brain.
BBQ
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