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Replies to #97735 on Biotech Values

rkrw

06/23/10 9:31 AM

#97741 RE: DonShimoda #97735

I'm sure they'll have guidance from the FDA of course and learned a few things from the panel on Omapro. They could use one centralized lab to validate T315i patients for example. I tend to think the fda focus on T315i testing for Omapro was an excuse to turn down what they knew was an ineffective drug.

But I wouldn't expect aria push for an SPA if that's what you mean. Why risk delaying things for an SPA when it's not necessary? They need to keep moving. SPA's can take months and months or more to negotiate and they box a company in. Design a good trial with a high bar and let the data speak for itself.

drbio45

06/23/10 9:46 AM

#97744 RE: DonShimoda #97735

ariad intends on recruiting patients for their trial that have failed at least two other tki's. They will have a predefined subgroup of t315i mutation patients. They do not intend on running a separate t315i mutation study