Timeline comparison to Gleevec..
Can we expect the same for Pharmagap??
1998: STI571 was first tested in a small study in people to determine whether it is safe. Doctors noticed that with higher doses, patients had dramatic positive responses to the drug.
1999: The preliminary results of this early study showed that 31 out of 31 patients who received at least 300 milligrams daily had their blood counts return to normal. In nine of the 20 patients who were treated for five months or longer, no cells with the Philadelphia chromosome could be found.
2001: February: Novartis submitted the New Drug Application for STI571, now known as Gleevec, to FDA for the treatment of the late phases of CML.
2001: April: Results of a larger study of STI571 in 83 patients were reported in New England Journal of Medicine. In the 54 chronic-phrase CML patients who were treated with doses of 300 milligrams or more, normal blood counts were restored in 53, and in 29 of the 54 patients, the Philadelphia chromosome disappeared. Most side effects were mild.
2001: May: U.S. Food and Drug Administration approved the sale of STI571/Gleevec for CML.