Elemer Piros comments on ICPT  : "Analysis of the two Phase IIb trials (FLINT and a Japanese study) unveils significant weaknesses. First and foremost, the primary endpoint that made the FLINT trial an apparent success is not used in the ongoing Phase III trial. Individual components of the co-primary endpoints of the Phase III trial were not significant in FLINT or in the Japanese study. To make matters worse, these endpoints are now co primary. We believe that the Phase III trial has at most a 25% chance to succeed."

Cantor's analyst Elemer Piros is brutal in his comments on Intercept Pharmaceuticals but the facts mentionned are undoubtely true.

For months, we analyzed on NASHBIOTECHS the different results published by ICPT and Sumitomo on OCA in NASH.

Many articles had pinned here the FLINT weaknesses 

and the implications of those weaknesses were also analyzed in the following articles


It is clear that the biggest challenge for ICPT now is to prove that, despite the incapacity to demonstrate an OCA action on NASH using the new NASH définition in the previous clinical studies, they have a chance to reach in their Phase 3 a goal never reached in Phase 2b.

Moreover, they have now to demonstrate they could have better results than GENFIT who demonstrated good results in Phase 2b, using the Phase 3 criteria, despite the unfavorable population selection criteria used in the 2 b study. 

GENFIT's phase 3 (in course), had improved in its design all the parameters and chances to reach again the endpoints they already reached in Phase 2b. 

It is a big challenge for ICPT but I am not as pessimistic as CANTOR, I am betting on a 35% chance of success for ICPT and 75% for GENFIT.

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