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Re: iwfal post# 202351

Sunday, 07/03/2016 8:06:26 PM

Sunday, July 03, 2016 8:06:26 PM

Post# of 257268
THLD -

The Japanese subset of the pancreatic ph3 does, in fact, look reasonable - although I'd want to see the Japanese data from the ph2's and Japanese ancestry data from RoW to get good confirmation.



FWIW it looks like the company has known since the ph2 that the Japanese cohort would respond differently to the drug - since they started a ph1 trial in Japan (PK, AE and efficacy) right at the end of the ph2 (as per clinicaltrials.org), and after they had started the ph3.

So I'd say, given the p value, the pre-knowledge, and the knowledge that Japanese can respond differently to cancer treatments... I'd suspect that this is real - but on the downside it implies that it had essentially no effect on the non-Japanese (my guess is that is the primary reason the FDA rejected it). So even if it works as a counter to IO resistance-via-hypoxia it seems risky to suppose it will work in non-Japanese.

BTW - Amusingly the XNCR Analyst Day apparently doubled the stock price of THLD from about 0.35 to about 0.70.

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