At best, the expanded access program was expected to provide safety data.
Still, some researchers aren't comfortable with the safety data.
It is approved for use in over 25 countries and has a long history of safety data.
"Combined with prior safety data, this altered our risk assessment."
The agency has asked the industry to provide it with safety data.
Also, there might be other reasons to continue, such as collecting more long-term safety data.
It was also debating rules that would force scientists to make public more of their safety data.
There is an almost complete lack of human safety data.
But the new safety data, he said, amounts to "a big why not" for many patients.
But she said she did not know whether the study's safety data had been presented.