Q 2 years seems like a short shelf life for cells stored in liquid nitrogen vapor phase - which goes to our inventory costs - why so short? Can that be extended with the FDA perhaps with some sort of comparative demonstration (perhaps a university project) showing cells at 3, 4 years, 5 etc are essentially the same?
[My comment - I read this two year reference somewhere reliable - probably a write up related to the nature medicine article about the phase 1 GvHD trial - but it doesn't make sense to me - it seems arbitrary or excessively cautious by someone (probably the FDA/CBER) given how cells usually behave in very cold storage].
Q 2 years seems like a short shelf life for cells stored in...
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