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Re: H2R post# 385752

Monday, 06/21/2021 3:58:04 PM

Monday, June 21, 2021 3:58:04 PM

Post# of 685958
I agree that the facility may be ready, and if this were a BP making mass produced drugs they could start production, but we're making personalized products which require patients to have leukapheresis and surgery before the product can be made. In order for the facility to produce, the company either needs people who're to receive the drug under compassionate use, or actually have approval from one or more of the regulators.

Without knowing what's happening behind the scenes with the regulators it's impossible to totally rule out a third quarter approval, but it's highly doubtful. As for compassionate use, we only know of a few cases, but they're mainly ones where public fundraising was being used to get our vaccine. Perhaps many are getting the vaccine using compassionate use who have the means to pay for it without fundraising, anyone have an idea of how high that may be.

Gary
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