Hi Semi-retired
The more I read about the FDA and SR-GvHD the more I have come to understand their reluctance to approve Ryoncil - the printscreen below is a big chunk of Dr Greg Bauer's bio on the FDA website (link here: https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/development-strategies-improve-cell-therapy-product-characterization).
Tell me that what is written below doesn't almost exactly correlate with their concerns raised about efficacy and potency of the cells in the CRL and the briefing paper to the ODAC committee.
Now it's not all bad news as I've mentioned previously Dr Galipeau (the president elect of the ISCT) has just released a paper (https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/stem.3380) discussing how these issues can be overcome so I'm super positive that we can get Dr Bauer across the line and get Ryoncil out to the market shortly.
Hi Semi-retiredThe more I read about the FDA and SR-GvHD the...
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