On Fri 11/13/15 before the announcement:
- Co announces that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the FDA, the agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. The company will provide this information in a Major Amendment to the FDA by close of business today.
- "We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer... We will continue to work diligently with the FDA on our NDA submission."
- As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected.
- Co anticipates that the review of this additional information will result in a delay of a potential approval. This additional review could lead to an extension of the Company's March 30, 2016 Prescription Drug User Fee Act (:PDUFA) date.
- CLVS believes it can still capture up to 40% market share.
- Co will hold conference call today at 8:30am ET.
- AstraZeneca (AZN) on Friday reported a 59% objective response for AZN's TAGRISSO, which the FDA approved.
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