Replies to post #458 on RedHill Biopharma Ltd (RDHL)

[Amatuer17]

This is supposed to be good news?
FDA agreed for CMC.

Does not seem that way.

The 1st phase 3 study had 120 patients. 1st patient was dosed in Dec'13 and last was dosed in Jun'15 and final results were published in Mar'16 - so total of 31 months

The 2nd study needs 440 patients - which is more than 3.5 time 1st study.

So we are looking at least 36 months from 1st patient dosing which will be before Jun'17

So we are looking at Jun'20 for funal results and add 9-12 months for approval and we reach Jun'21 which is far too out.

Maybe that is giving it a negative impact.