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mcbio

11/12/12 1:48 PM

#152175 RE: DonShimoda #152171

CLVS - LEAP failure CC

1. CLVS has two years of remaining cash.

2. CLVS plans to continue to develop both CO-1686 and rucaparib on their own.

3. This was actually from a prior CC, but the CO-1686 patents run to 2030.

4. CLVS expects to have Phase 1 data, more along the lines of safety and PK/PD, for both CO-1686 and rucaparib at ASCO 2013. Actual PoC data for 1686 is expected in 2H2013 (didn't catch timeline for rucaparib PoC data).

5. CLVS expects to initiate pivotal trial for CO-1686 in 2014 and expects to be able to go from IND to NDA in 4 years (this might have been the timeline for rucaparib as well but not 100% certain on that).

6. I'll add that it was refreshing that management didn't try to sugarcoat the LEAP failure in the CC. The CEO made a point to specifically mention that they could try to data dredge and try to come up with something but they wouldn't do that and he stressed that the trial was a complete failure. Makes me trust management and the company more.