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GENFIT ($GNFTF) announced today (Apr 11 2018) that recruitment of the patient cohort (1000 patients) for accelerated approval has been reached in RESOLV’IT.  Intercept ($ICPT) announced in may 2017 that they had closed interim recruitment (750 patients) in REGENERATE.

GENFIT provided details on this recruitment and that baseline data on the first 1,000 randomized patients shows good distribution of patient recruitment worldwide. As their Phase 2b was jeopardized because of a fast non-balanced recruitment, GENFIT decided to take its time on phase 3.

They selected cohort regarding balanced distribution of treatments across all sites and countries, based on stratification according to gender, diabetes, and disease severity. In the international setting, patients have been enrolled in more than 250 sites across North America, Europe, Australia, Latin America, Turkey and South Africa.

The purpose of this is clear, they bet on an accelerated FDA approval because of their representative cohort. They learned from the delayed agreement of OCA in PBC because of a non-representative panel of patients that was different from FDA expectations.

We can hope that INTERCEPT also learned from that, because as they planned initially to recruit 1400 patients for interim results, they announced in march 2017 that they decided to reduce the cohort to 750 only and never transmitted data’s on their interim cohort profile.

This choice seems mainly conducted by their decision to keep the lead on timing but will undoubtedly weak the future strength of REGENERATE trial.

The number of patients recruited by arms (3 arms) for interim results will be 250 and one can bet that, at the end, because of potential loss, results would be presented on less than 230 patients per OCA arms (vs 230 placebo).

To compare, ELAFIBRANOR arm in interim results of RESOLV’IT ( 2 arms) will include 666 patients and, because of potential loss, results on ELAFIBRANOR arm would be presented on almost 600 patients (vs 300 placebo). 

If the ELAFIBRANOR cohort is very well balanced as GENFIT declared, the time lost in recruitment selection can be recovered in FDA analysis and could facilitate an accelerated agreement.

It would be interesting for INTERCEPT to provide some data’s on their interim recruitment baselines to let analysts evaluate  possible misfits in agreement delay by FDA.

G Divry

Notice that I am neither a physician nor a biologist or financial analyst, my point of view is only that of an enlightened amateur, so it must be taken for what it is, a questionable point of view

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