Saturday, November 27, 2021 10:27:55 AM
Lykiri,
You might want to ask something like “What clinical pathway might FDA recommend when working with a company developing a novel cell therapy over a 14 year period in an orphan indication but might be waiting on a guidance change to be published before moving forward?” then add that the “stay tuned” pathway has worn so thin that it’s falling on deaf ears because so many patients that could have benefitted are no longer alive ; ). Best wishes.
You might want to ask something like “What clinical pathway might FDA recommend when working with a company developing a novel cell therapy over a 14 year period in an orphan indication but might be waiting on a guidance change to be published before moving forward?” then add that the “stay tuned” pathway has worn so thin that it’s falling on deaf ears because so many patients that could have benefitted are no longer alive ; ). Best wishes.
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