Please describe your background, how many patients you treat in each EGFR-NSCLC subset, and how these patients get to you.

Can you describe the current available treatment options, particularly Roche's Tarceva, AstraZeneca's Iressa and Tagrisso, and Boehringer Ingelheim's Gilotrif and how they compare to rociletinib? How do you currently treat your patients?

Can you describe the other NSCLC drugs currently in development, particularly AstraZeneca's durvalumab, Pfizer's dacomitinib, and Novartis' EGF816, and how they compare to rociletinib?

Rociletinib is being evaluated across various subsets of NSCLC patients. Their ongoing studies include TIGER-X (phase I/II-advanced population), TIGER-1 (phase II/III-newly diagnosed patients), TIGER-2 (T790M-positive and T790M-negative patients after first and only TKI therapy), and TIGER-3 (T790M-positive and T790M-negative patients with acquired TKI resistance). Can you describe the standard measures for these subsets and tell us how consistent the endpoints are in the various studies?

What have these various trials told you about rociletinib? Has the drug shown more potential in a particular subset of patients or have the results been consistent across each group? 

Investors in Clovis suffered great losses when the FDA decided to postpone the PDUFA date after they requested additional data for both the 500mg and 625 mg dose groups. The request said that the NDA contained immature data sets based on both unconfirmed and confirmed response rates. How has the data changed going in to the June PDUFA date? How do you expect the advisory committee to respond to the data in April?

According to Patrick J. Mahaffy, President and CEO of Clovis, "new treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer." Do you agree with this statement? Is rociletinib a better treatment for this subset in particular than the entire TGFR-NSCLC population?

How are patients in the mutant EGFR T790M-positive subset currently treated? How does rociletinib compare to these treatments? 

Given the current data and drug history, what are the chances rociletinib is approved by the FDA?

Assuming the drug gets approved, what percentage of new patients in the mutant EGFR T790M-positive subset will be prescribed rociletinib? What percentage of these existing patients will switch to rociletinib? 

Assuming the drug gets approved, what percentage of new patients in the other subsets will be prescribed rociletinib? What percentage of existing patients in these subsets will switch to rociletinib? 

It is estimated that NSCLC accounts for about 85%-90% of all lung cancer cases, 10% of patients with NSCLC have EGFR mutations, and about 60% of patients with mutant-EGFR related NSCLC carry the T790M mutation. Are these accurate numbers to use in estimates of the potential market for rociletinib?