Julie Zawisza
Julie Zawisza
bulk lots product sell three
may sell product from the three bulk lots that we just released.
bulk gate released spot three
We released three bulk lots. There have been spot shortages because Chiron got out of the gate late.
bulk gate released spot three
We released three bulk lots, ... There have been spot shortages because Chiron got out of the gate late.
comments decide public review soon taking
We will review the public comments as soon as practicable and, taking those comments into account, decide how to proceed.
company discuss issue
We did issue this approvable letter, but we can't discuss what's in the letter. Only the company can do that.
integrity partial process question results
We question the integrity of the investigative process that results in such partial conclusions by the G.A.O.,
point public technology
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?
accustomed handling lengthy product reviewing
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.
both designed donor expect follow handling people processing protect screening stringent tissue
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.
failed few patients people sick treatments
It's only for treatment-resistant patients -- people who have failed many other treatments and are very very sick with few other options.
cant confirm release terms trial
We cant even confirm to you there is a trial. If we release information, it jeopardizes the trial in terms of competitiveness to get to market.