We released three bulk lots, ... There have been spot shortages because Chiron got out of the gate late.
We did issue this approvable letter, but we can't discuss what's in the letter. Only the company can do that.
We already have stringent regulations in place for tissue donor screening and for handling and processing tissue. These regulations are designed to protect both the tissue donor and recipient, and we expect people to follow these rules.
It's really a public airing of the issues. We have the technology. We have a product. Are we at the point we can do this in the home?
We can't even confirm to you there is a trial. If we release information, it jeopardizes the trial in terms of competitiveness to get to market.
We question the integrity of the investigative process that results in such partial conclusions by the G.A.O.,
May sell product from the three bulk lots that we just released.
We are very accustomed to handling complicated and sometimes lengthy product evaluations, and we don't 'give up' just because we may be reviewing a controversial device.
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