EX, you know as well as anyone here that you cannot apply if you don't have a commercial production facility ready for inspection in a timely manner.
Clearly the EDEN is NWBO's choice for commercial production. I'm uncertain if the EDEN was permitted for compassionate use, if it was the record there ought to be sufficient. Again, an EUA for the EDEN would be an answer permitting its use could be an answer.
Time and cost never seem to matter to the regulators, they're going to do things there way and if it takes many years and costs hundreds of millions more, they don't seem to care, nor do they care about all who won't get the benefits.
All this could also be prevented if the right to try program was changed so that all developers would participate. Few do because to do so corporate proprietary information must be divulged and few are willing to do so. As long as right to try would also cover the use of the EDEN, it should work here the way the compassionate use program is working in the UK.
On the other hand, if you said you can try it under right to try, but it must be made manually, you'd have the same production problem that is the case today.
Gary
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