Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Adam Walsh with Jefferies & Co.
Adam Walsh, M.D. - Jefferies & Co.
My first question is do you happen to know which day you will be presenting data at ASCO?
David S. Barlow
June 2. It’s a poster session from 2-5 p.m.
Adam Walsh, M.D. - Jefferies & Co.
On Azedra for pheo, your analysts, Drs. Goldsmith and Coleman, had talked about some of the dosimetry trials and they had mentioned surprise that you had been able to get up to 9 millicuries at that point in time that cohort was enrolling. I am wondering if you can give us a little bit of an update on whether or not we’ve seen DLT in that cohort and whether or not you’ve actually been able to go beyond 9 millicuries.
John W. Babich, Ph.D.
We had to repeat that 9 millicurie cohort and we are currently observing that group. So right now we do not have another DLT in that group but the observation period is not completed.
Adam Walsh, M.D. - Jefferies & Co.
In some of the earlier cohorts there had been at least one DLT and a couple of cohorts that was low platelets. Is that what you’re seeing at this point in the 9 millicurie cohort.
John W. Babich, Ph.D.
That’s correct. That’s the standard toxicity associated with MIGB therapy and that you wind up with thrombocytopenia and potentially also reduction in white cell count. But these we cover spontaneously.
Adam Walsh, M.D. - Jefferies & Co.
And on Onalta, at what time would you anticipate launching into a pivotal 2-3 trial for pancreatic neuroendocrine tumors?
David S. Barlow
What we have to do first, particularly in order to complete some open issues with the FDA is complete our dosimetry study. And that will actually then be a jumping-off point for initiating any therapeutic trial.
Adam Walsh, M.D. - Jefferies & Co.
I know it’s hard to predict with these dosimetry trials, but do you have a ballpark guestimate of how long you think it might take the dosimetry trial to play out before you could get into a pivotal situation?
David S. Barlow
I think you’re talking about 6-9 months maybe for recruiting and collating all the data that we need to then go back to the FDA.
Operator
Your next question comes from Debjit Chattopadhyay with Boenning Scattergood.
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