In the most recent cc, Berger said the company would start a single arm, registration trial as soon as they received approval (irregardless of whether they had a partner). My take is that now that Merck has taken over development of Ridaforolimus, Ariad now has the resources (and the experience) to push forward on their own. Additionally, I suspect the AP534 trial will be significantly smaller than the Rida trial (650 pts) which may give Berger further confidence in initially pursuing the registration trial independently.
I suspect the decision on whether to ultimately partner AP534 will depend on the market opportunity 534 has not only as a second line drug but also as a potential first line treatment option for high risk pts such as those with the T315I mutation. Clearly, first line status would require large, head to head, multi-arm trials and significant resources (and the impact that Gleevec coming off patent in 2015 needs to be factored in). However if Ariad can reach approval based on a relatively small, single-arm trial with pts who have failed 2 TKI's or have the T315I mutation, then a partnership closer to NDA, imo, may optimize shareholder value.
