Trial 106 Lynn and anyone else interested

[Guest guest]

Hello Folks,

You might want to know that part of the process that allowed

Novartis (and will be the same for BMS if I am not mistaken)

to " fast track " Gleevec through the approval process meant that they

needed to provide continuous data, post approval, to the FDA (and

other governments where applicable)on patients and outcomes for a

specified period. In the case of Novartis, from what I understand,

they needed to provide this data starting January 2004 which means

they should provide it for at least another year. Importantly,

Novartis is compelled to provide annual reports to the FDA

specifically on patients in trial 106. Failure to do so would

result in a warning or possibly a fine to be issued to Novartis.

Which none of us wold like to see.

Lynn, if I were you, I would get in touch with Novartis in NJ, first

going through the medical information department, and aprise them of

your situation.

Anyone else who is facing the situation of being removed from this

trial should contact Novartis immediately.

Hope this helps, and please let us know what the outcome is.

Best,

Cheryl-Anne