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Re: biocqr post# 213633

Wednesday, 09/13/2017 7:35:57 PM

Wednesday, September 13, 2017 7:35:57 PM

Post# of 252302
FGEN / IPF Trials:

Your Pirfenidone trial numbers are off because they included the CAPACITY trials remember one of them was positive so that gave them 2 positive trials.

A straight placebo trial IMO (actually for IPF I think they need 2 trials don't know if FDA would accept 1 since both approved drugs have 2) would need closer to 1000 patients. I am not sure how much more you would need if your going for non-inferiority.

I was an ITMN long (so may be biased) but would say their data is slightly better then BI's. But neither drug is extremely efficacious and both have their AE's. I heard/read that discontinuations are about 25% annually.

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