Replies to post #20775 on Ariad Pharmaceuticals Inc fka ARIA

[DonShimoda]

The trial will be conducted at up to 175 investigational sites in North America, Europe and
Asia-Pacific.

In compariason, the P2 trial is in 68 sites. The additional locations should build a lot of awareness/momentum going into ponatinibs' launch.

[DonShimoda]

The trial is powered to show a 15% absolute improvement in MMR over gleevec in newly diagnosed CP patients. As the press release points out the MMR in the tasigna and sprycel trials was 22% and 28%, respectively. Using the average in these two trials of 25%, would require ponatinib to achieve a 40% MMR to meet the primary endpoint. For reference, in the phase 2 trial, ponatinib achieved a 37% MMR in just over 10 months in patients who had already failed at least 2 other tki's. I like our chances, lol.

[gym gravity]

I smell financing soon!

[iandy]

A key design feature of the trial is an interim analysis of efficacy. This analysis will take place 12 months after half of the patients in the trial have been randomized. The interim analysis will focus on the primary endpoint of the MMR rate at 12 months of treatment and, depending on the results, may allow ARIAD to file for regulatory approval of ponatinib in the newly diagnosed clinical setting approximately six months earlier than otherwise.

I wonder what the best case scenario might be.
Front line approval in approximately 20 - 24 months?