may sell product from the three bulk lots that we just released.
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 will review the public comments as soon as practicable and, taking those comments into account, decide how to proceed.
We did issue this approvable letter, but we can't discuss what's in the letter. Only the company can do that.
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.
We released three bulk lots. There have been spot shortages because Chiron got out of the gate late.
We released three bulk lots, ... There have been spot shortages because Chiron got out of the gate late.
We question the integrity of the investigative process that results in such partial conclusions by the G.A.O.,
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 only for treatment-resistant patients -- people who have failed many other treatments and are very very sick with few other options.
