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Re: longfellow95 post# 251835

Saturday, 11/16/2019 4:22:32 PM

Saturday, November 16, 2019 4:22:32 PM

Post# of 731959
Longfellow95,

Thank you for the article (Spark looks at scale, manufacturing as gene therapy matures). I remember reading it a while ago and i think you brought it to my attention then. So, thank you!

I want to emphasize this quote (in bold):

Our [Biologics License Application], when we filed it with the FDA and similarly with the EMA, was like 60,000 pages.
The vast majority of it wasn't about the clinical data. It was about CMC, or chemistry, manufacturing and controls, which is all about how our process works, how we control for it and how we show reproducibility.


https://www.biopharmadive.com/news/spark-gene-therapy-manufacturing-scale-cmc/545723/
I wonder if the compagny will wait to unblind the trial until the production process is finalized in the UK.

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