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Re: DewDiligence post# 213021

Thursday, 08/10/2017 8:32:46 PM

Thursday, August 10, 2017 8:32:46 PM

Post# of 257264
Re: GLPG P2 IPF data CC slides

So, my FGEN bias notwithstanding, there were several others (h/t @sport234a @subset_member @bio_clouseau) that today posted on Twitter some fairly bearish takes on the P2 GLPG IPF data based on the CC slides. In addition to the very small patient numbers and limited 12-week duration of data, other points included:

1. The FVC data is not based on the intent-to-treat (ITT) population. How would the data change if data on full ITT population was reported?

2. Slide 13 shows change in FVC over time but there are varying numbers of patients reported at differing time points. E.g., at week 4 data is shown for 3 placebo patients but then at the week 8 point data is for some reason shown based on 4 placebo patients. Why was the fourth patient on placebo not included in the data at the week 4 point and how would that change the totality of the data if included there? Also, why were 3 placebo patients (out of only 6 total) removed from the data set at some point between baseline and week 4?

3. The placebo actually appears to outperform the drug from week 4 to week 12 and from week 4 to follow-up.

All told, I certainly can't entirely dismiss the GLPG IPF threat to FGEN, but I also don't feel as concerned about this potential competitive threat as I did upon reading the initial PR.

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